Hepatopulmonary SyndromePhase 2NCT01518595
Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis
A Phase 2 study testing bosentan in people with Hepatopulmonary Syndrome and Liver Cirrhosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatopulmonary Syndrome, Liver Cirrhosis
- What is being tested?
- bosentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2011to Apr 2014
- Phase
- Phase 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
- Presence of HPS
- Age ≥ 18 years
Who cannot join
- Intracardiac shunting
- Pregnancy
- Known hypersensitivity to bosentan
- Use of glyburide
- Use of cyclosporin A
- Elevation of aminotransferase level of > 3 times the upper limit of normal
Show all 11Show fewer
- Use of rifampicin
- Females of childbearing potential without use of adequate contraception
- Systolic blood pressure < 85 mmHg
- Clinical relevant anemia
- HIV-infection
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology
Vienna, 1090
About this study
Official title: Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study
The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to date, the only therapeutic option is liver transplantation. The study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS according to the ERS task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration of the study is 2 years.
- Conditions
- Hepatopulmonary Syndrome, Liver Cirrhosis
- Being tested
- bosentan, Placebo
- Keywords
- patients
- Medical subject headings
- Hepatopulmonary Syndrome, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
pts. will receive bosentan for 3 months
PlaceboDrug
pts. will receive placebo for 3 months
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Patients will receive placebo tablets twice daily for 3 months. Receives: Drug: Placebo |
| bosentan | Active comparator | pts. will receive bosentan for 3 months Receives: Drug: bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar-arterial oxygen gradient in mmHg
Measured: 3 months
Secondary outcomes (10)
presence of HPS
assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing
Measured: 3 months
6 minutes walking distance in m
Measured: 3 months
WHO functional class
Measured: 3 months
quality of life
we will us the CAT-questionaire for QoL assessment
Measured: 3 months
aminotransferase level (ASAT, ALAT)
Assessment of the aminotransferase levels in U/L
Measured: 3 months
exhanled nitric oxide in parts per billion
Measured: 3 months
hepatic venous pressure gradient (HVPG) in mmHg
HVPG will be assessed after inclusion in the study and after 3 months
Measured: 3 months
pulmonary hemodynamics
pulmonary hemodynamics will be assessed after inclusion and after 3 months
Measured: 3 months
mean arterial blood pressue in mmHg
Measured: 3 months
partial pressure of arterial oxygen in mmHg
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2014
Why it stopped: too slow patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatopulmonary SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentin Fuhrmann, Medical University of Vienna
- Investigators
- Valentin H Fuhrmann, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518595
- Sponsor's protocol ID
- 1-Fuhrmann
- Status last verified
- Sep 2016
- First submitted
- 26 Oct 2011
- Last updated
- 28 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01518595
- Acronym / sponsor ID
- 1-Fuhrmann
- Conditions
- Hepatopulmonary Syndrome, Liver Cirrhosis
- Keywords
- patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too slow patient recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- First posted
- 26 Jan 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.
The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to date, the only therapeutic option is liver transplantation. The study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS according to the ERS task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration of the study is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo tablets twice daily for 3 months. |
| bosentan | Active comparator | Drug: bosentanpts. will receive bosentan for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of HPS
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- Intracardiac shunting
- Pregnancy
- Known hypersensitivity to bosentan
- Use of glyburide
- Use of cyclosporin A
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 |
|---|---|---|
| bosentanpts. will receive bosentan for 3 months | Drug | bosentan |
| Placebopts. will receive placebo for 3 months | Drug | placebo |
Primary outcome
alveolar-arterial oxygen gradient in mmHg
Time frame: 3 months
10 secondary outcomes
presence of HPS
Time frame: 3 months
6 minutes walking distance in m
Time frame: 3 months
WHO functional class
Time frame: 3 months
quality of life
Time frame: 3 months
aminotransferase level (ASAT, ALAT)
Time frame: 3 months
exhanled nitric oxide in parts per billion
Time frame: 3 months
hepatic venous pressure gradient (HVPG) in mmHg
Time frame: 3 months
pulmonary hemodynamics
Time frame: 3 months
mean arterial blood pressue in mmHg
Time frame: 3 months
partial pressure of arterial oxygen in mmHg
Time frame: 3 months
Results and safety
The study was stopped early (reason given: too slow patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
Related trials for Hepatopulmonary Syndrome
Enrolling by invitationObservational study
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
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.
Valentin H Fuhrmann, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bosentan in people with Hepatopulmonary Syndrome and Liver Cirrhosis, run by Medical University of Vienna 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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 stopped early (reason given: too slow patient recruitment). Results are not available in the source record.
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?
alveolar-arterial oxygen gradient in mmHg (time frame: 3 months). 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 28 Sep 2016.