<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03301506</url>
  </required_header>
  <id_info>
    <org_study_id>CB8025-31731</org_study_id>
    <nct_id>NCT03301506</nct_id>
  </id_info>
  <brief_title>Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)</brief_title>
  <official_title>ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CymaBay Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CymaBay Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in&#xD;
      Subjects with Primary Biliary Cholangitis (PBC)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary:&#xD;
&#xD;
      To evaluate the long-term safety and tolerability of seladelpar&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        -  To evaluate the long-term efficacy of seladelpar&#xD;
&#xD;
        -  To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 12, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>60 Months</time_frame>
    <description>Occurrence of overall death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver transplantation</measure>
    <time_frame>60 Months</time_frame>
    <description>Occurrence of overall liver transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MELD</measure>
    <time_frame>60 Months</time_frame>
    <description>MELD score ≥ 15 for at least 2 consecutive visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ascites</measure>
    <time_frame>60 Months</time_frame>
    <description>Occurrence of overall ascites requiring treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for variceal bleeding</measure>
    <time_frame>60 Months</time_frame>
    <description>Hospitalization for new onset, or recurrence, of variceal bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for hepatic encephalopathy</measure>
    <time_frame>60 Months</time_frame>
    <description>Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for spontaneous bacterial peritonitis</measure>
    <time_frame>60 Months</time_frame>
    <description>Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on composite endpoint</measure>
    <time_frame>60 Months</time_frame>
    <description>Alkaline phosphate (ALP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on composite endpoint</measure>
    <time_frame>60 Months</time_frame>
    <description>Total bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normalization of ALP</measure>
    <time_frame>60 Months</time_frame>
    <description>Proportion of subjects with normalization of ALP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Value: Serum Alkaline Phosphatase (ALP)</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
    <description>Serum Alkaline Phosphatase (ALP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Value: Aspartate Aminotransferase (AST)</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
    <description>Aspartate Aminotransferase (AST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Value: Alanine Aminotransferase (ALT)</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
    <description>Alanine Aminotransferase (ALT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Value: Gamma-glutamyl Transferase (GGT)</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
    <description>Gamma-glutamyl Transferase (GGT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Value: Bilirubin - Total Bilirubin</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
    <description>Bilirubin - Total Bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Value: Bilirubin - Conjugated Bilirubin</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
    <description>Bilirubin - Conjugated Bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Value: Bilirubin - Unconjugated Bilirubin</measure>
    <time_frame>Through study completion, up to 60 Months</time_frame>
    <description>Bilirubin - Unconjugated Bilirubin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Primary Biliary Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Seladelpar 5 mg Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Seladelpar 10 mg Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seladelpar 5 mg Capsule</intervention_name>
    <description>Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.</description>
    <arm_group_label>Seladelpar 5 mg Capsules</arm_group_label>
    <other_name>MBX-8025</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seladelpar 10 mg Capsule</intervention_name>
    <description>Subjects will be assigned to a treatment group unless there are tolerability issues.</description>
    <arm_group_label>Seladelpar 10 mg Capsule</arm_group_label>
    <other_name>MBX-8025</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must have given written informed consent (signed and dated)&#xD;
&#xD;
          2. Participated in a PBC study with seladelpar&#xD;
&#xD;
          3. Females of reproductive potential must use at least one barrier contraceptive and a&#xD;
             second effective birth control method during the study and for at least 90 days after&#xD;
             the last dose. Male subjects who are sexually active with female partners of&#xD;
             reproductive potential must use barrier contraception and their female partners must&#xD;
             use a second effective birth control method during the study and for at least 90 days&#xD;
             after the last dose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria are only applicable for subjects with a seladelpar interruption greater&#xD;
        than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838&#xD;
        irrespective of seladelpar interruption.&#xD;
&#xD;
          1. Treatment-related adverse event (AE) leading to seladelpar discontinuation in a&#xD;
             previous PBC study with seladelpar (MBX-8025)&#xD;
&#xD;
          2. A medical condition, other than PBC, that in the investigator's opinion would preclude&#xD;
             full participation in the study or confound its results (e.g., cancer)&#xD;
&#xD;
          3. AST or ALT above 3 × the upper limit of normal (ULN)&#xD;
&#xD;
          4. Total bilirubin above 2 × ULN&#xD;
&#xD;
          5. MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the&#xD;
             baseline INR, in concert with any current dose adjustments in anti-coagulant&#xD;
             medications, will be taken into account when calculating this score. This will be done&#xD;
             in consultation with the medical monitor.&#xD;
&#xD;
          6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the&#xD;
             lower limit of normal (LLN) AND total bilirubin above 1 × ULN)&#xD;
&#xD;
          7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)&#xD;
&#xD;
          8. Auto-immune hepatitis&#xD;
&#xD;
          9. Primary sclerosing cholangitis&#xD;
&#xD;
         10. Known history of alpha-1-antitrypsin deficiency&#xD;
&#xD;
         11. Known history of chronic viral hepatitis&#xD;
&#xD;
         12. For females, pregnancy or breast-feeding&#xD;
&#xD;
         13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids&#xD;
             (e.g. prednisone, prednisolone, budesonide) (&gt;2 weeks) within 2 months prior to&#xD;
             Screening&#xD;
&#xD;
         14. Current use of fibrates or use of fibrates within 3 months prior to Screening&#xD;
&#xD;
         15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to&#xD;
             Screening&#xD;
&#xD;
         16. Use of an experimental or unapproved treatment for PBC within 3 months prior to&#xD;
             Screening&#xD;
&#xD;
         17. History of malignancy diagnosed or treated, actively or within 2 years, or active&#xD;
             evaluation for malignancy; localized treatment of squamous or non-invasive basal cell&#xD;
             skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior&#xD;
             to Screening&#xD;
&#xD;
         18. Treatment with any other investigational therapy or medical device within 30 days or&#xD;
             within 5 half-lives, whatever is longer, prior to Screening&#xD;
&#xD;
         19. Any other condition(s) that would compromise the safety of the subject or compromise&#xD;
             the quality of the clinical study, as judged by the Investigator&#xD;
&#xD;
         20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other&#xD;
             immunosuppressive biologics)&#xD;
&#xD;
         21. Other medications that effect liver or GI functions such as absorption of medications&#xD;
             or the roux-en-y gastric bypass procedure may be prohibited and should be discussed&#xD;
             with the medical monitor on a case-by-case basis&#xD;
&#xD;
         22. Positive for:&#xD;
&#xD;
               1. Hepatitis B, defined as the presence of hepatitis B surface antigen&#xD;
&#xD;
               2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)&#xD;
&#xD;
               3. Human immunodeficiency virus (HIV) antibody&#xD;
&#xD;
         23. Active COVID-19 infection during screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Barry Crittenden, MD</last_name>
    <phone>510-293-8800</phone>
    <email>medinfo@cymabay.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Arkansas Diagnostic Centre</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>California Liver Research Institute</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center- Sutter Pacific Medical Foundation</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Covenant Metabolic Specialist LLC</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Florida Digestive Health Specialist</name>
      <address>
        <city>Lakewood Ranch</city>
        <state>Florida</state>
        <zip>34211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Schiff Center for Liver Diseases/University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Covenant Metabolic Specialist LLC</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Digestive Healthcare of Georgia</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Institutional Review Board</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tulane Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48377</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MNGI Digestive Health, P.A.</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55117</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Southern Therapy and Advanced Research (STAR), LLC</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwell Health Center for Liver Diseases</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center - PPDS</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northeast Clinical Research Center, LLC</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UPMC Center for Liver Diseases</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Galen Hepatology</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gastro One</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Hepatology and Liver Transplant</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Liver Institute at Methodist Dallas Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>U.T. Southwestern Medical Center Investigation Drug Service</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>American Research Corporation at the Texas Liver Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pinnacle Clinical Research, PLLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maryview Hospital Inc</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Richmond Community Hospital LLC., d/b/a Bon Secours Liver Institute of Richmond</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Liver Institute Northwest</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CINME (Centro de Investigaciones Metabolicas</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1056ABJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aries</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <state>Buenos Aires</state>
        <zip>C1199ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DIM Clinica Privada</name>
      <address>
        <city>Ramos Mejía</city>
        <state>Buenos Aires</state>
        <zip>B1704ETD</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de la Plata</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aries</state>
        <zip>B1900AX</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane &amp; Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen GmbH</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Calgary Medicine</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro Clinico Mediterraneo</name>
      <address>
        <city>La Serena</city>
        <state>Coquimbo</state>
        <zip>1720506</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Interni a Kardiologicka Klinika-Oddeleni Gastroenterologie a Hepatologie</name>
      <address>
        <city>Ostrava</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik Tubingen, Medizinische Klinik, Innere Medizin I</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Wurttemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Erlangen, Medizinische Klink I, Gastroenterologie</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gastroenterologische Gemeinschaftspraxis</name>
      <address>
        <city>Herne</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44623</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gastroenterologisch - Hepatologisches Zentrum Kiel</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24146</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charite Universitatsmedizin Berlin, Medizinische Poliklinik</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ifi-Medizin GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>General University Hospital of Larissa Department of Medicine and Research Laboratory of Internal Medicine</name>
      <address>
        <city>Larissa</city>
        <state>Thessaly</state>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <state>Ulloi</state>
        <zip>1082</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Somogy Megyei Kaposi Mor Oktato Korhaz</name>
      <address>
        <city>Kaposvár</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center - PPDS</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Liver Disease Center, Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center PPDS</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ASST di Monza</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara</name>
      <address>
        <city>Baggiovara</city>
        <state>Modena</state>
        <zip>41126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Soon Chun Hyang University Hospital Bucheon</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggi-do</state>
        <zip>14584</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Centre</name>
      <address>
        <city>Sŏngdong</city>
        <state>Seoul</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Consultorio Medico - Distrito Federal</name>
      <address>
        <city>Ciudad de Mexico</city>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Consultorio de la Doctora Maria Sarai Gonzalez Huezo</name>
      <address>
        <city>Metepec</city>
        <zip>52140</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Radboudumc/Research Unit MDL</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <state>Canterbury</state>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <state>Otago</state>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Gastroenterologii i Hepatologii</name>
      <address>
        <city>Katowice</city>
        <zip>40-752</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ID Clinic Arkadiusz Pisula</name>
      <address>
        <city>Myslowice</city>
        <zip>41-400</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundeni Clinical Institute</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Federal State Autonomous Educational Institution of Higher Education &quot;Peoples' Friendship University of Russia&quot;, Centre of Liver Studies</name>
      <address>
        <city>Moscow</city>
        <zip>117198</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Federal state budget educational institution of high education &quot;Stavropol state medical university&quot;</name>
      <address>
        <city>Stavropol</city>
        <zip>355017</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Ulyanovsk Regional Clinical Hospital</name>
      <address>
        <city>Ulyanovsk</city>
        <zip>432063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>0896</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital clinic De Barcelona</name>
      <address>
        <city>Barcelone</city>
        <state>Barcelona</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ankara Gazi University Faculty of Medicine Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06560</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ankara Sehir Hastanesi, Universiteler Mahallesi</name>
      <address>
        <city>Ankara</city>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ege University Medical Faculty, Kazimdirik Mah</name>
      <address>
        <city>İzmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Portsmouth Hospitals University NHS Trust</name>
      <address>
        <city>Portsmouth</city>
        <state>Hampshire</state>
        <zip>P06 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital Birmingham</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital Birmingham - Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B152TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hull University Teaching Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E11FR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospital NHS Foundation Trust</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE4 5PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle</city>
        <zip>NE45PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PBC</keyword>
  <keyword>Primary Biliary Cholangitis (PBC)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Liver Cirrhosis, Biliary</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seladelpar</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03301506
org study id: CB8025-31731
nct id: NCT03301506
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in
      Subjects with Primary Biliary Cholangitis (PBC)
Primary:

      To evaluate the long-term safety and tolerability of seladelpar

      Secondary:

        -  To evaluate the long-term efficacy of seladelpar

        -  To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
time frame: Through study completion, up to 60 Months
measure: Death
time frame: 60 Months
description: Occurrence of overall death
measure: Liver transplantation
time frame: 60 Months
description: Occurrence of overall liver transplantation
measure: Change in MELD
time frame: 60 Months
description: MELD score ≥ 15 for at least 2 consecutive visits
measure: Ascites
time frame: 60 Months
description: Occurrence of overall ascites requiring treatment
measure: Hospitalization for variceal bleeding
time frame: 60 Months
description: Hospitalization for new onset, or recurrence, of variceal bleeding
measure: Hospitalization for hepatic encephalopathy
time frame: 60 Months
description: Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)
measure: Hospitalization for spontaneous bacterial peritonitis
time frame: 60 Months
description: Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
measure: Response on composite endpoint
time frame: 60 Months
description: Alkaline phosphate (ALP)
measure: Response on composite endpoint
time frame: 60 Months
description: Total bilirubin
measure: Normalization of ALP
time frame: 60 Months
description: Proportion of subjects with normalization of ALP
measure: Laboratory Value: Serum Alkaline Phosphatase (ALP)
time frame: Through study completion, up to 60 Months
description: Serum Alkaline Phosphatase (ALP)
measure: Laboratory Value: Aspartate Aminotransferase (AST)
time frame: Through study completion, up to 60 Months
description: Aspartate Aminotransferase (AST)
measure: Laboratory Value: Alanine Aminotransferase (ALT)
time frame: Through study completion, up to 60 Months
description: Alanine Aminotransferase (ALT)
measure: Laboratory Value: Gamma-glutamyl Transferase (GGT)
time frame: Through study completion, up to 60 Months
description: Gamma-glutamyl Transferase (GGT)
measure: Laboratory Value: Bilirubin - Total Bilirubin
time frame: Through study completion, up to 60 Months
description: Bilirubin - Total Bilirubin
measure: Laboratory Value: Bilirubin - Conjugated Bilirubin
time frame: Through study completion, up to 60 Months
description: Bilirubin - Conjugated Bilirubin
measure: Laboratory Value: Bilirubin - Unconjugated Bilirubin
time frame: Through study completion, up to 60 Months
description: Bilirubin - Unconjugated Bilirubin
arm group label: Seladelpar 5 mg Capsules
arm group type: Experimental
arm group label: Seladelpar 10 mg Capsule
arm group type: Experimental
intervention type: Drug
intervention name: Seladelpar 5 mg Capsule
description: Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.
arm group label: Seladelpar 5 mg Capsules
other name: MBX-8025
intervention type: Drug
intervention name: Seladelpar 10 mg Capsule
description: Subjects will be assigned to a treatment group unless there are tolerability issues.
arm group label: Seladelpar 10 mg Capsule
other name: MBX-8025
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Barry Crittenden, MD
phone: 510-293-8800
email: medinfo@cymabay.com
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
country: Argentina
country: Australia
country: Austria
country: Belgium
country: Canada
country: Chile
country: Czechia
country: France
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Korea, Republic of
country: Mexico
country: Netherlands
country: New Zealand
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Turkey
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Cholangitis
mesh term: Liver Cirrhosis, Biliary
mesh term: Seladelpar