Portopulmonary HypertensionPhase 1/2NCT01733095
Ambrisentan for Treatment of Portopulmonary Hypertension
A Phase 1/2 study testing ambrisentan in people with Portopulmonary Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portopulmonary Hypertension
- What is being tested?
- ambrisentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2012to Jun 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study
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.
Read the 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.
- Conditions
- Portopulmonary Hypertension
- Being tested
- ambrisentan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambrisentanDrug
Also called Volibris
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary vascular resistance
Measured: week 24
Secondary outcomes (4)
mean arterial pulmonary pressure
Measured: week 24
hepatic venous pressure gradient
Measured: week 24
exercise capacity
Measured: week 24, 48
quality of life
Measured: week 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2016
- Study completionJun 2016
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portopulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf E. Stauber, MD, Principal investigator, Gastroenterology & HepatologyHorst Olschewski, MD, Study director, Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733095
- Sponsor's protocol ID
- PoPH-GRZ ambrisentan
- Status last verified
- Jun 2016
- First submitted
- 20 Nov 2012
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study
- ClinicalTrials.gov ID
- NCT01733095
- Acronym / sponsor ID
- PoPH-GRZ ambrisentan
- Conditions
- Portopulmonary Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ambrisentan | Experimental | Drug: ambrisentanIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ambrisentanAlso: VolibrisAmbrisentan (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. | Drug | ambrisentan |
Primary outcome
pulmonary vascular resistance
Time frame: week 24
4 secondary outcomes
mean arterial pulmonary pressure
Time frame: week 24
hepatic venous pressure gradient
Time frame: week 24
exercise capacity
Time frame: week 24, 48
quality of life
Time frame: week 24, 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
Related trials for Portopulmonary Hypertension
Not yet recruitingObservational study
Heart Problems in Children With Chronic Liver Disease
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Not yet recruitingObservational study
Genetic Hallmarks of Patients With Congenital Portosystemic Shunts and Portopulmonary Hypertension
Portopulmonary Hypertension, Pulmonary Arterial Hypertension (PAH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf E. Stauber, MD principal investigator
Gastroenterology & Hepatology
Horst Olschewski, MD study director
Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ambrisentan in people with Portopulmonary Hypertension, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary vascular resistance (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.