Ambrisentan for Treatment of Portopulmonary Hypertension

NCT01733095 | Withdrawn Phase 1

• 1 other identifier: PoPH-GRZ ambrisentan
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Portopulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• pulmonary vascular resistance

  week 24

Secondary Outcomes (4)

• mean arterial pulmonary pressure

  week 24

• hepatic venous pressure gradient

  week 24

• exercise capacity

  week 24, 48

• quality of life

  week 24, 48

Study Arms (1)

ambrisentan

EXPERIMENTAL

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.

Drug: ambrisentan

Interventions

ambrisentan DRUG

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.

Also known as: Volibris

ambrisentan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with portal hypertension, age \>18 years
• Cirrhosis of any etiology; Child-Pugh class A and B
• Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)
• Informed consent

You may not qualify if:

• Presence of other causes for pulmonary arterial hypertension
• History of pulmonary embolism or myocardial infarction within 6 months before study start
• Child-Pugh class C
• Presence of hepatocellular carcinoma
• Liver transplantation
• HIV infection
• Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC \<65%, respectively)
• Severe dilated cardiomyopathy (EF \<50%)
• Latent left-heart insufficiency
• Pregnancy and lactation
• Esophageal variceal hemorrhage within the last 6 months
• Refractory ascites
• Hepatorenal syndrome
• Persistent hepatic encephalopathy \> grade 1
• Bilirubin \>3.0 mg/dl

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Interventions

ambrisentan

Study Officials

• Rudolf E. Stauber, MD

  Gastroenterology & Hepatology

  PRINCIPAL INVESTIGATOR

• Horst Olschewski, MD

  Pulmonology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

AU (1)