CompletedNCT00631475BUILD OLUpdated Feb 4, 2025Results posted

Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443

A Phase 3 interventional study of Bosentan in Idiopathic Pulmonary Fibrosis, sponsored by Actelion. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Actelion · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 128
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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).

Conditions studied

Idiopathic Pulmonary Fibrosis

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Keywords

Actelion
Idiopathic Pulmonary Fibrosis
bosentan
Tracleer
Interstitial Lung Disease
BUILD 3 (NCT00391443)

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 128 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 128 participants (actual)

Study arms

Experimental
1
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
Drug: Bosentan

Interventions

DrugBosentan
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.)
Also known as: Tracleer

What researchers measure

Primary outcomes

Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Mean extent of exposure to bosentan treatment in months
Time frame: Start of study to end of study, up to 21 months

Secondary outcomes

Number of Patients Exposed to Bosentan Over Time
Numbers of participants exposed to bosentan treatment over time
Time frame: 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.
Time frame: 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.
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.
Number of participants with an increase in ALT and/or AST to \> 3 times upper limit of normal during the study.
Time frame: up to 21 months, plus 24 hours after the end of study treatment

Results

Posted Aug 3, 2012

Participant flow

Patients were enrolled at 61 centers in 15 countries (Australia, Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, South Korea, , Spain, Switzerland, UK, and USA. The first patient started on 5 March 2008 and the last patient, last visit was on 01 April 2010.

Participant flow — Overall Study
Milestone	Bosentan Treatment
Started	128
Completed	83
Not completed	45
Withdrew: Death	18
Withdrew: Adverse event	14
Withdrew: Withdrew consent	5
Withdrew: Preparation for lung transplant	8

Outcome measures

PrimaryExtent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Mean extent of exposure to bosentan treatment in months

Time frame:: Start of study to end of study, up to 21 months
Reported as:: Mean · months

Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
months	Bosentan Treatment
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)	6.4 ± 4.6

SecondaryNumber of Patients Exposed to Bosentan Over Time

Numbers of participants exposed to bosentan treatment over time

Time frame:: Start to end of study, up to 21 months
Reported as:: Number · Participants

Number of Patients Exposed to Bosentan Over Time
Participants	Bosentan Treatment
For at least 4 months	74
For at least 8 months	44
For at least 12 months	17
For at least 16 months	7
For at least 20 months	2

SecondaryAdverse Events (AE) Leading to Discontinuation of Study Drug.

Number of participants with at least one AE that led to permanent discontinuation of study treatment.

Time frame:: Start to end of study, up to 21 months
Reported as:: Number · participants

Adverse Events (AE) Leading to Discontinuation of Study Drug.
participants	Bosentan Treatment
Adverse Events (AE) Leading to Discontinuation of Study Drug.	32

SecondaryTreatment-emergent Serious Adverse Events (SAE)

Number of participants with at least one SAE during the study.

Time frame:: up to 21 months plus 28 days after the end of study drug
Reported as:: Number · participants

Treatment-emergent Serious Adverse Events (SAE)
participants	Bosentan Treatment
Treatment-emergent Serious Adverse Events (SAE)	51

SecondaryOccurrence 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.

Time frame:: up to 21 months, plus 24 hours after the end of study treatment
Reported as:: Number · participants

Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
participants	Bosentan Treatment
Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.	3

Adverse events

Collected over Up to 28 days after the end of study drug. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bosentan Treatment	—	51/128 (39.8%)	5/128 (3.9%)

Most frequent serious events

Showing 10 of 43

Most frequent serious events
Event	Bosentan Treatment
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders	23/128
Respiratory failureRespiratory, thoracic and mediastinal disorders	4/128
Lower respiratory tract infectionInfections and infestations	4/128
PneumoniaInfections and infestations	4/128
DyspnoeaRespiratory, thoracic and mediastinal disorders	3/128
Lung transplantSurgical and medical procedures	3/128
Coronary artery diseaseCardiac disorders	2/128
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	1/128
Pleuritic painRespiratory, thoracic and mediastinal disorders	1/128
PneumothoraxRespiratory, thoracic and mediastinal disorders	1/128

Most frequent other events

Most frequent other events
Event	Bosentan Treatment
LIVER FUNCTION TEST ABNORMALInvestigations	2/128
DYSPNOEARespiratory, thoracic and mediastinal disorders	1/128
IDIOPATHIC PULMONARY FIBROSISRespiratory, thoracic and mediastinal disorders	1/128
OEDEMA PERIPHERALGeneral disorders	1/128

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Bosentan Treatment
Mean	65.4 ± 8.2

Age, Customized
Age, Customized(participants)	Bosentan Treatment
18-40 years	1
41-60 years	33
61-70 years	62
>70 years	32

Sex: Female, Male
Sex: Female, Male(Participants)	Bosentan Treatment
Female	31
Male	97

Region of Enrollment
Region of Enrollment(participants)	Bosentan Treatment
Australia	12
Belgium	1
Canada	14
Czech Republic	1
France	3
Germany	11
Ireland	1
Israel	4
Italy	2
Japan	8
Korea, Republic of	5
Spain	8
Switzerland	4
United Kingdom	3
United States	51

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00631475
Lead sponsor: Actelion
Responsible party: Sponsor
First posted: Mar 7, 2008
Start date: Apr 2008
Primary completion: Apr 2010
Completion: May 2010
Results posted: Aug 3, 2012
Last update: Feb 4, 2025

Study contacts

Isabelle Leconte

study chair · Actelion

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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