<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/NCT04454463</url>
  </required_header>
  <id_info>
    <org_study_id>NAFLD Database 3</org_study_id>
    <secondary_id>U01DK061732</secondary_id>
    <secondary_id>U01DK061713</secondary_id>
    <secondary_id>U01DK061737</secondary_id>
    <secondary_id>U01DK061718</secondary_id>
    <secondary_id>U01DK061734</secondary_id>
    <secondary_id>U01DK061738</secondary_id>
    <secondary_id>U01DK061728</secondary_id>
    <secondary_id>U01DK061731</secondary_id>
    <secondary_id>U24DK061730</secondary_id>
    <nct_id>NCT04454463</nct_id>
  </id_info>
  <brief_title>Nonalcoholic Fatty Liver Disease (NAFLD) Database 3</brief_title>
  <official_title>Nonalcoholic Fatty Liver Disease (NAFLD) Database 3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liver Institute Northwest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients&#xD;
      suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the&#xD;
      cooperative effort of a multidisciplinary and multicenter group of collaborators, the&#xD;
      etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular&#xD;
      its more severe form of NASH and its complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, prospective follow-up study of patients with known nonalcoholic fatty&#xD;
      liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). The primary objective of the&#xD;
      study is to investigate the etiology, pathogenesis, natural history, diagnosis, treatment,&#xD;
      and prevention of NAFLD and NASH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 13, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in alanine aminotransferase (ALT) levels from baseline to one year.</measure>
    <time_frame>Baseline and 1 year</time_frame>
    <description>ALT measure in IU/L (higher ALT indicates worse outcomes)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2250</enrollment>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Adult patients with NAFLD</arm_group_label>
    <description>1500 patients 18 years and older at the time of enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pediatric patients with NAFLD</arm_group_label>
    <description>750 patients 2 years or older and up to 17 years old at the time of enrollment.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma, serum, liver tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be at least 2250 patients age 2 years or older with&#xD;
        histologically confirmed NAFLD or NASH located in the United States:&#xD;
&#xD;
          -  1500 patients 18 years and older at the time of enrollment.&#xD;
&#xD;
          -  750 patients 2 years or older and up to 17 years old at the time of enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2 years of age or older as of the initial screening interview and provision of consent&#xD;
&#xD;
          -  Willingness to participate in the study for 1 or more years&#xD;
&#xD;
          -  Histologic evidence of NAFLD or NASH based upon a standard of care liver biopsy&#xD;
&#xD;
          -  Collection of serum and plasma up to 90 days before or 4- 90 days after standard of&#xD;
             care liver biopsy&#xD;
&#xD;
          -  Absence of regular or excessive use of alcohol within 2 years prior to initial&#xD;
             screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical or histological evidence of alcoholic liver disease: Regular and excessive&#xD;
             use of alcohol within the 2 years prior to interview defined as alcohol intake greater&#xD;
             than 14 drinks per week in a man or greater than 7 drinks per week in a woman.&#xD;
             Approximately 10 g of alcohol equals one 'drink' unit. One unit equals 1 ounce of&#xD;
             distilled spirits, one 12-oz beer, or one 4-oz glass of wine&#xD;
&#xD;
          -  Total parenteral nutrition for more than 1 month within a 6-month period before&#xD;
             baseline liver biopsy&#xD;
&#xD;
          -  Short bowel syndrome&#xD;
&#xD;
          -  History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD. Bariatric&#xD;
             surgery performed following enrollment is not exclusionary. Liver biopsies obtained&#xD;
             during bariatric surgery cannot be used for enrollment because of the associated&#xD;
             surgical or anesthetic acute changes and the weight loss efforts that precede&#xD;
             bariatric surgery&#xD;
&#xD;
          -  History of biliopancreatic diversion&#xD;
&#xD;
          -  Evidence of advanced liver disease defined as a Child-Pugh-Turcotte score equal to or&#xD;
             greater than 10&#xD;
&#xD;
          -  Evidence of chronic hepatitis B as marked by the presence of HBsAg in serum (patients&#xD;
             with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)&#xD;
&#xD;
          -  Evidence of chronic hepatitis C as marked by the presence of anti-HCV or HCV RNA in&#xD;
             serum&#xD;
&#xD;
          -  Low alpha-1-antitrypsin level and ZZ phenotype (both determined at the discretion of&#xD;
             the investigator)&#xD;
&#xD;
          -  Wilson's disease&#xD;
&#xD;
          -  Known glycogen storage disease&#xD;
&#xD;
          -  Known dysbetalipoproteinemia&#xD;
&#xD;
          -  Known phenotypic hemochromatosis (HII greater than 1.9 or removal of more than 4 g of&#xD;
             iron by phlebotomy)&#xD;
&#xD;
          -  Prominent bile duct injury (florid duct lesions or periductal sclerosis) or bile duct&#xD;
             paucity&#xD;
&#xD;
          -  Chronic cholestasis&#xD;
&#xD;
          -  Vascular lesions (vasculitis, cardiac sclerosis, acute or chronic Budd-Chiari,&#xD;
             hepatoportal sclerosis, peliosis)&#xD;
&#xD;
          -  Iron overload greater than 3+&#xD;
&#xD;
          -  Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis&#xD;
&#xD;
          -  Multiple epithelioid granulomas&#xD;
&#xD;
          -  Congenital hepatic fibrosis&#xD;
&#xD;
          -  Polycystic liver disease&#xD;
&#xD;
          -  Other metabolic or congenital liver disease&#xD;
&#xD;
          -  Evidence of systemic infectious disease&#xD;
&#xD;
          -  Known HIV positive&#xD;
&#xD;
          -  Disseminated or advanced malignancy&#xD;
&#xD;
          -  Concomitant severe underlying systemic illness that in the opinion of the investigator&#xD;
             would interfere with completion of follow-up&#xD;
&#xD;
          -  Active drug use or dependence that, in the opinion of the study investigator, would&#xD;
             interfere with adherence to study requirements&#xD;
&#xD;
          -  Any other condition, which in the opinion of the investigator would impede compliance&#xD;
             or hinder completion of study&#xD;
&#xD;
          -  Inability to complete the appropriate informed consent process&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arun Sanyal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brent Tetri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Louis University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peggy Adamo, MS</last_name>
    <phone>410-502-9137</phone>
    <email>madamo1@jhu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emily Mitchell, MPH</last_name>
    <phone>410-955-8183</phone>
    <email>esharke5@jhu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, San Diego- Adults</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Egbert Madamba</last_name>
      <phone>858-246-2227</phone>
      <email>emadamba@health.ucsd.edu</email>
    </contact>
    <contact_backup>
      <last_name>Lisa Richards</last_name>
      <phone>(858) 246-2254</phone>
      <email>lrichards@health.ucsd.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Rohit Loomba, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daisy Olvera</last_name>
      <phone>323-442-0535</phone>
      <email>daisy.olvera@med.usc.edu</email>
    </contact>
    <investigator>
      <last_name>Norah Terrault, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego Pediatrics</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paty Ugalde-Nicalo</last_name>
      <phone>619-543-7673</phone>
      <email>pugaldenicalo@ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Jeffrey Schwimmer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rae Davis</last_name>
      <phone>415-514-3274</phone>
      <email>rayshawnda.davis@ucsf.edu</email>
    </contact>
    <contact_backup>
      <last_name>Remi Awe</last_name>
      <phone>(415) 502-2906</phone>
      <email>remilekun.awe@ucsf.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Norah Terrault, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bilal Hameed, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University-Pediatrics</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmen Garcia</last_name>
      <phone>404-727-9876</phone>
      <email>cgarc40@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Miriam Vos, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Riordan</last_name>
      <phone>312-227-4558</phone>
      <email>mriordan@luriechildrens.org</email>
    </contact>
    <contact_backup>
      <last_name>Angela Anthony</last_name>
      <phone>(312) 227-4559</phone>
      <email>aanthony@luriechildrens.org</email>
    </contact_backup>
    <investigator>
      <last_name>Mark Fishbein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Indiana University- Adults</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Garrison</last_name>
      <phone>317-278-3206</phone>
      <email>ljgarris@iu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mandy Cruz</last_name>
      <phone>(317) 278-6210</phone>
      <email>mandcruz@iu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Naga Chalasani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wendy Morlan</last_name>
      <phone>317-274-9601</phone>
      <email>wmorlan@iu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kelley Jackson</last_name>
      <phone>317-974-9671</phone>
      <email>ksj4@iu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jean Molleston, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theresa Cattoor, RN</last_name>
      <phone>314-977-9355</phone>
      <email>theresa.cattooor@health.slu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Shirley Campbell</last_name>
      <phone>(314) 977-9336</phone>
      <email>shirley.campbell@health.slu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Brent Tetri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ajay Jain, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </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>
    <contact>
      <last_name>Mariko Kopping</last_name>
      <phone>919-684-4798</phone>
      <email>mariko.kopping@duke.edu</email>
    </contact>
    <contact_backup>
      <last_name>Naglaa Tawadrous</last_name>
      <phone>(919) 668-5819</phone>
      <email>naglaa.tawadrous@duke.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Anna Mae Diehl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229-3039</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Popelar</last_name>
      <phone>516-636-8867</phone>
      <email>ann.popelar@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>Stavra Xanthakos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marialena Mouzaki, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rahul Yerrapothu</last_name>
      <phone>216-445-4863</phone>
      <email>yerrapr@ccf.org</email>
    </contact>
    <contact_backup>
      <last_name>Annette Bellar</last_name>
      <phone>(216) 636-5247</phone>
      <email>bellara@ccf.org</email>
    </contact_backup>
    <investigator>
      <last_name>Srinivasan Dasarathy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital, Baylor University</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cynthia Tsai</last_name>
      <phone>832-822-3634</phone>
      <email>ct2@bcm.edu</email>
    </contact>
    <contact_backup>
      <last_name>Donna Garner</last_name>
      <phone>832-822-4009</phone>
      <email>dkgarner@bcm.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Paula Hertel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherry Boyett</last_name>
      <phone>804-828-5434</phone>
      <email>sherry.boyett@vcuhealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Jolene Schlosser</last_name>
      <phone>(804) 828-9195</phone>
      <email>jolene.schlosser@vcuhealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Arun J Sanyal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <contact>
      <last_name>Theresa Dorrian</last_name>
      <phone>206-536-3030</phone>
      <email>tdorrian@liverinstitutenw.org</email>
    </contact>
    <contact_backup>
      <last_name>Pannapat Angkanaworakul</last_name>
      <phone>(206) 536-3030</phone>
      <email>pannapat@liverinstitutenw.org</email>
    </contact_backup>
    <investigator>
      <last_name>Kris Kowdley, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital- SEA</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Young</last_name>
      <phone>206-987-1037</phone>
      <email>melissa.young@seattlechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Niviann Blondet, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://jhuccs1.us/nash/</url>
    <description>Nonalcoholic Steatohepatitis Clinical Research Consortium</description>
  </link>
  <link>
    <url>http://www2.niddk.nih.gov/</url>
    <description>The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NAFLD</keyword>
  <keyword>NASH</keyword>
  <keyword>non-alcoholic steatohepatitis</keyword>
  <keyword>fatty liver disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The NASH CRN is fully committed to resource sharing beyond the NASH CRN investigators. The NASH CRN will make deposits to the NIDDK Central Data Repository according to the requirements outlined in the NIDDK Data Sharing Policy published in July 2013.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within two years of end of the funding cycle.</ipd_time_frame>
    <ipd_access_criteria>All qualified investigators will be allowed access to the stored materials at the end of a pre-determined proprietary period.</ipd_access_criteria>
    <ipd_url>https://repository.niddk.nih.gov/home/</ipd_url>
  </patient_data>
  <!-- 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/NCT04454463
org study id: NAFLD Database 3
secondary id: U01DK061732
secondary id: U01DK061713
secondary id: U01DK061737
secondary id: U01DK061718
secondary id: U01DK061734
secondary id: U01DK061738
secondary id: U01DK061728
secondary id: U01DK061731
secondary id: U24DK061730
nct id: NCT04454463
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients
      suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the
      cooperative effort of a multidisciplinary and multicenter group of collaborators, the
      etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular
      its more severe form of NASH and its complications.
This is a multicenter, prospective follow-up study of patients with known nonalcoholic fatty
      liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). The primary objective of the
      study is to investigate the etiology, pathogenesis, natural history, diagnosis, treatment,
      and prevention of NAFLD and NASH.
observational model: Cohort
time perspective: Prospective
measure: Change in alanine aminotransferase (ALT) levels from baseline to one year.
time frame: Baseline and 1 year
description: ALT measure in IU/L (higher ALT indicates worse outcomes)
arm group label: Adult patients with NAFLD
description: 1500 patients 18 years and older at the time of enrollment.
arm group label: Pediatric patients with NAFLD
description: 750 patients 2 years or older and up to 17 years old at the time of enrollment.
plasma, serum, liver tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Arun Sanyal, MD
role: Principal Investigator
affiliation: Virginia Commonwealth University Medical Center
last name: Brent Tetri, MD
role: Principal Investigator
affiliation: St Louis University Hospital
last name: Peggy Adamo, MS
phone: 410-502-9137
email: madamo1@jhu.edu
last name: Emily Mitchell, MPH
phone: 410-955-8183
email: esharke5@jhu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://jhuccs1.us/nash/
description: Nonalcoholic Steatohepatitis Clinical Research Consortium
url: http://www2.niddk.nih.gov/
description: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: Yes
ipd description: The NASH CRN is fully committed to resource sharing beyond the NASH CRN investigators. The NASH CRN will make deposits to the NIDDK Central Data Repository according to the requirements outlined in the NIDDK Data Sharing Policy published in July 2013.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Within two years of end of the funding cycle.
ipd access criteria: All qualified investigators will be allowed access to the stored materials at the end of a pre-determined proprietary period.
ipd url: https://repository.niddk.nih.gov/home/