Pulmonary Arterial HypertensionPhase 4NCT00625469
Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
A Phase 4 study testing bosentan in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Fibrosis, run by Rajan Saggar at 2 sites in United States.
Trial summary
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis
- What is being tested?
- bosentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic Pulmonary Fibrosis referred for lung transplantation
- Minimum 50 meter 6 minute walk distance
- No significant underlying liver disease
Who cannot join
- Significant liver disease or cirrhosis
- non ambulatory
- previous adverse reaction/allergy to Bosentan
Trial locations and contacts
2 sites in 1 country.
United States2 sites
David Geffen School of Medicine UCLA
Los Angeles, California, 90095-1690
Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1690
About this study
Official title: Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.
Read the detailed description
The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.
- Being tested
- bosentan
- Keywords
- pulmonary arterial hypertension, idiopathic pulmonary fibrosis, bosentan
- Medical subject headings
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
Also called tracleer
62.5mg orally bid for first month, followed by 125mg bid thereafter
| Study group | Role | What they receive |
|---|---|---|
| treatment with bosentan | Experimental | patients with resting or exercise induced PAH receive bosentan in a randomized open label fashion Receives: Drug: bosentan |
| PAH group with no therapy | No intervention | patients with resting or exercise PAH get randomized to receive no specific therapy |
| No PAH and no therapy | No intervention | patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk distance
ATS Guideline 6MW distance before and after intervention
Measured: monthly assessement until date of lung transplantation
Secondary outcomes (2)
right heart catheterization hemodynamics
pulmonary hemodynamics
Measured: variable based on time between listing and actual lung transplantation
chemokine peripheral blood analysis
battery of chemokines analyzed from the peripheral blood
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: competing studies did not allow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajan Saggar
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Sponsor-investigator, Rajan Saggar, University of California, Los Angeles
- Investigators
- Rajan Saggar, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625469
- Sponsor's protocol ID
- IPF/PAH
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2008
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT00625469
- Acronym / sponsor ID
- IPF/PAH
- Keywords
- pulmonary arterial hypertension, idiopathic pulmonary fibrosis, bosentan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: competing studies did not allow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rajan SaggarUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- Oct 2007 (actual)
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 28 Feb 2008 (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.
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.
Detailed description
The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treatment with bosentan | Experimental | Drug: bosentanpatients with resting or exercise induced PAH receive bosentan in a randomized open label fashion |
| PAH group with no therapy | No intervention | –patients with resting or exercise PAH get randomized to receive no specific therapy |
| No PAH and no therapy | No intervention | –patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Pulmonary Fibrosis referred for lung transplantation
- Minimum 50 meter 6 minute walk distance
- No significant underlying liver disease
Key exclusion criteria (3 listed)
- Significant liver disease or cirrhosis
- non ambulatory
- previous adverse reaction/allergy to Bosentan
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 |
|---|---|---|
| bosentanAlso: tracleer62.5mg orally bid for first month, followed by 125mg bid thereafter | Drug | treatment with bosentan |
Primary outcome
6 minute walk distance
Time frame: monthly assessement until date of lung transplantation
ATS Guideline 6MW distance before and after intervention
2 secondary outcomes
right heart catheterization hemodynamics
Time frame: variable based on time between listing and actual lung transplantation
chemokine peripheral blood analysis
Time frame: monthly
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 6 Mar 2018.
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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.
Rajan Saggar, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bosentan in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Fibrosis, run by Rajan Saggar at 2 sites in United States.
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 3 inclusion and 3 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
6 minute walk distance (time frame: monthly assessement until date of lung transplantation). 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 6 Mar 2018.