Ambrisentan for Treatment of Portopulmonary Hypertension | NCT01733095

Studies
Ambrisentan for Treatment of Portopulmonary Hypertension

NCT01733095

Sponsor

Medical University of Graz

Status

Withdrawn

Last Update Posted

Jun 17, 2016Estimated

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Portopulmonary Hypertension

Interventions

ambrisentan

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow recruitment

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Apr 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 20, 2012

First Submission Date that Met QC Criteria

Nov 20, 2012

First Posted Date

Nov 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2016

Last Update Posted Date

Jun 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pulmonary vascular resistance		week 24

Secondary Outcomes

Measure	Description	Time Frame
mean arterial pulmonary pressure		week 24
hepatic venous pressure gradient		week 24
exercise capacity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
AST and/or ALT >3x ULN
Creatinine >2.0 mg/dl
Known hypersensitivity to ambrisentan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rudolf E. Stauber, MD	Gastroenterology & Hepatology	Principal Investigator
Horst Olschewski, MD	Pulmonology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz		8036	Austria