<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/NCT01733095</url>
  </required_header>
  <id_info>
    <org_study_id>PoPH-GRZ ambrisentan</org_study_id>
    <nct_id>NCT01733095</nct_id>
  </id_info>
  <brief_title>Ambrisentan for Treatment of Portopulmonary Hypertension</brief_title>
  <official_title>Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension&#xD;
      and is present in approximately 5% of cirrhotic patients. Treatment options include&#xD;
      prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.&#xD;
&#xD;
      This study investigates the safety and efficacy of ambrisentan in portopulmonary&#xD;
      hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with clinically significant PoPH (resting mean pulmonary arterial pressure &gt;25 mm&#xD;
      Hg, pulmonary vascular resistance &gt;400 dynes*s*cm-5) will be offered treatment with&#xD;
      ambrisentan. Patients will be followed clinically and hemodynamically up to 12 months after&#xD;
      start of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    slow recruitment&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pulmonary vascular resistance</measure>
    <time_frame>week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean arterial pulmonary pressure</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hepatic venous pressure gradient</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>exercise capacity</measure>
    <time_frame>week 24, 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>week 24, 48</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Portopulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>ambrisentan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In all patients with clinically significant PoPH, ambrisentan will be administered orally using a low ascending dose regime (see below). Duration of treatment will be 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ambrisentan</intervention_name>
    <description>Ambrisentan (Volibris 5 mg film-coated tablets, Glaxo Smith-Kline) will be started at 5 mg every other day and increased to 5 mg daily after 4 weeks if tolerated well.</description>
    <arm_group_label>ambrisentan</arm_group_label>
    <other_name>Volibris</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with portal hypertension, age &gt;18 years&#xD;
&#xD;
          -  Cirrhosis of any etiology; Child-Pugh class A and B&#xD;
&#xD;
          -  Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other causes for pulmonary arterial hypertension&#xD;
&#xD;
          -  History of pulmonary embolism or myocardial infarction within 6 months before study&#xD;
             start&#xD;
&#xD;
          -  Child-Pugh class C&#xD;
&#xD;
          -  Presence of hepatocellular carcinoma&#xD;
&#xD;
          -  Liver transplantation&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC &lt;65%,&#xD;
             respectively)&#xD;
&#xD;
          -  Severe dilated cardiomyopathy (EF &lt;50%)&#xD;
&#xD;
          -  Latent left-heart insufficiency&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Esophageal variceal hemorrhage within the last 6 months&#xD;
&#xD;
          -  Refractory ascites&#xD;
&#xD;
          -  Hepatorenal syndrome&#xD;
&#xD;
          -  Persistent hepatic encephalopathy &gt; grade 1&#xD;
&#xD;
          -  Bilirubin &gt;3.0 mg/dl&#xD;
&#xD;
          -  AST and/or ALT &gt;3x ULN&#xD;
&#xD;
          -  Creatinine &gt;2.0 mg/dl&#xD;
&#xD;
          -  Known hypersensitivity to ambrisentan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rudolf E. Stauber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gastroenterology &amp; Hepatology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Horst Olschewski, MD</last_name>
    <role>Study Director</role>
    <affiliation>Pulmonology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>June 16, 2016</last_update_submitted>
  <last_update_submitted_qc>June 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ambrisentan</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/NCT01733095
org study id: PoPH-GRZ ambrisentan
nct id: NCT01733095
lead sponsor: 
has dmc: No
Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension
      and is present in approximately 5% of cirrhotic patients. Treatment options include
      prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.

      This study investigates the safety and efficacy of ambrisentan in portopulmonary
      hypertension.
Patients with clinically significant PoPH (resting mean pulmonary arterial pressure >25 mm
      Hg, pulmonary vascular resistance >400 dynes*s*cm-5) will be offered treatment with
      ambrisentan. Patients will be followed clinically and hemodynamically up to 12 months after
      start of treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pulmonary vascular resistance
time frame: week 24
measure: mean arterial pulmonary pressure
time frame: week 24
measure: hepatic venous pressure gradient
time frame: week 24
measure: exercise capacity
time frame: week 24, 48
measure: quality of life
time frame: week 24, 48
arm group label: ambrisentan
arm group type: Experimental
description: In all patients with clinically significant PoPH, ambrisentan will be administered orally using a low ascending dose regime (see below). Duration of treatment will be 12 months.
intervention type: Drug
intervention name: ambrisentan
description: Ambrisentan (Volibris 5 mg film-coated tablets, Glaxo Smith-Kline) will be started at 5 mg every other day and increased to 5 mg daily after 4 weeks if tolerated well.
arm group label: ambrisentan
other name: Volibris
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rudolf E. Stauber, MD
role: Principal Investigator
affiliation: Gastroenterology & Hepatology
last name: Horst Olschewski, MD
role: Study Director
affiliation: Pulmonology
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Ambrisentan