Idiopathic Pulmonary FibrosisPhase 3BUILD OLNCT00631475
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
A Phase 3 study testing Bosentan in people with Idiopathic Pulmonary Fibrosis, run by Actelion.
Trial summary
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 128 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.
- Signed informed consent prior to initiation of any study-related procedures.
- Women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.
Who cannot join
- Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).
- Pregnancy or breast-feeding.
- AST and/or ALT > 3 times the upper limit of the normal range.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
- Known hypersensitivity to bosentan or any of the excipients.
About this study
Official title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Bosentan
- Keywords
- Actelion, Idiopathic Pulmonary Fibrosis, bosentan, Tracleer, Interstitial Lung Disease, BUILD 3 (NCT00391443)
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Also called Tracleer
For patients who were administered Bosentan during BUILD 3 (NCT00391443):
continue on same dose
For patients who were administered placebo during BUILD 3 (NCT00391443):
Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | For patients who were administered bosentan during BUILD 3 (NCT00391443):
Same dose will continue
For patients who were administered placebo during BUILD 3 (NCT00391443):
Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg Receives: Drug: Bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Mean extent of exposure to bosentan treatment in months
Measured: Start of study to end of study, up to 21 months
Secondary outcomes (4)
Number of Patients Exposed to Bosentan Over Time
Numbers of participants exposed to bosentan treatment over time
Measured: Start to end of study, up to 21 months
Adverse Events (AE) Leading to Discontinuation of Study Drug.
Number of participants with at least one AE that led to permanent discontinuation of study treatment.
Measured: Start to end of study, up to 21 months
Treatment-emergent Serious Adverse Events (SAE)
Number of participants with at least one SAE during the study.
Measured: up to 21 months plus 28 days after the end of study drug
Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.
Measured: up to 21 months, plus 24 hours after the end of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle Leconte, Study chair, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631475
- Sponsor's protocol ID
- AC-052-322
- Acronym
- BUILD OL
- Status last verified
- Jan 2025
- First submitted
- 12 Feb 2008
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
- ClinicalTrials.gov ID
- NCT00631475
- Acronym / sponsor ID
- BUILD OL / AC-052-322
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Actelion, Idiopathic Pulmonary Fibrosis, bosentan, Tracleer, Interstitial Lung Disease, BUILD 3 (NCT00391443)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 3 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BosentanFor patients who were administered bosentan during BUILD 3 (NCT00391443): Same dose will continue For patients who were administered placebo during BUILD 3 (NCT00391443): Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.
- Signed informed consent prior to initiation of any study-related procedures.
- Women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.
Key exclusion criteria (5 listed)
- Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).
- Pregnancy or breast-feeding.
- AST and/or ALT > 3 times the upper limit of the normal range.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
- Known hypersensitivity to bosentan or any of the excipients.
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: TracleerFor patients who were administered Bosentan during BUILD 3 (NCT00391443): continue on same dose For patients who were administered placebo during BUILD 3 (NCT00391443): Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.) | Drug | 1 |
Primary outcome
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Time frame: Start of study to end of study, up to 21 months
Mean extent of exposure to bosentan treatment in months
4 secondary outcomes
Number of Patients Exposed to Bosentan Over Time
Time frame: Start to end of study, up to 21 months
Adverse Events (AE) Leading to Discontinuation of Study Drug.
Time frame: Start to end of study, up to 21 months
Treatment-emergent Serious Adverse Events (SAE)
Time frame: up to 21 months plus 28 days after the end of study drug
Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
Time frame: up to 21 months, plus 24 hours after the end of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Isabelle Leconte study chair
Actelion
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bosentan in people with Idiopathic Pulmonary Fibrosis, run by Actelion.
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 5 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: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) (time frame: Start of study to end of study, up to 21 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 4 Feb 2025.