Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-07 @ 6:56 AM
Study NCT ID:
NCT01733095
Status:
WITHDRAWN
Last Update Posted:
2016-06-17
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambrisentan for Treatment of Portopulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C467894', 'term': 'ambrisentan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'slow recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pulmonary vascular resistance', 'timeFrame': 'week 24'}], 'secondaryOutcomes': [{'measure': 'mean arterial pulmonary pressure', 'timeFrame': 'week 24'}, {'measure': 'hepatic venous pressure gradient', 'timeFrame': 'week 24'}, {'measure': 'exercise capacity', 'timeFrame': 'week 24, 48'}, {'measure': 'quality of life', 'timeFrame': 'week 24, 48'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Portopulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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.\n\nThis study investigates the safety and efficacy of ambrisentan in portopulmonary hypertension.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with portal hypertension, age \\>18 years\n* Cirrhosis of any etiology; Child-Pugh class A and B\n* Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)\n* Informed consent\n\nExclusion Criteria:\n\n* Presence of other causes for pulmonary arterial hypertension\n* History of pulmonary embolism or myocardial infarction within 6 months before study start\n* Child-Pugh class C\n* Presence of hepatocellular carcinoma\n* Liver transplantation\n* HIV infection\n* Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC \\<65%, respectively)\n* Severe dilated cardiomyopathy (EF \\<50%)\n* Latent left-heart insufficiency\n* Pregnancy and lactation\n* Esophageal variceal hemorrhage within the last 6 months\n* Refractory ascites\n* Hepatorenal syndrome\n* Persistent hepatic encephalopathy \\> grade 1\n* Bilirubin \\>3.0 mg/dl\n* AST and/or ALT \\>3x ULN\n* Creatinine \\>2.0 mg/dl\n* Known hypersensitivity to ambrisentan'}, 'identificationModule': {'nctId': 'NCT01733095', 'briefTitle': 'Ambrisentan for Treatment of Portopulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study', 'orgStudyIdInfo': {'id': 'PoPH-GRZ ambrisentan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ambrisentan', '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.', 'interventionNames': ['Drug: ambrisentan']}], 'interventions': [{'name': 'ambrisentan', 'type': 'DRUG', 'otherNames': ['Volibris'], '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.', 'armGroupLabels': ['ambrisentan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Rudolf E. Stauber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastroenterology & Hepatology'}, {'name': 'Horst Olschewski, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pulmonology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}