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

Phase 3

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Bosentan

• Registration Number: NCT00631475
• Lead Sponsor: Actelion

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-03-07
• Study Start: 2008-04
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Results First Submitted: 2012-06-19
• Results First Submitted QC: 2012-06-19
• Results First Posted: 2012-08-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bosentan	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Patients Exposed to Bosentan Over Time	Start to end of study, up to 21 months	Numbers of participants exposed to bosentan treatment over time
Adverse Events (AE) Leading to Discontinuation of Study Drug.	Start to end of study, up to 21 months	Number of participants with at least one AE that led to permanent discontinuation of study treatment.
Treatment-emergent Serious Adverse Events (SAE)	up to 21 months plus 28 days after the end of study drug	Number of participants with at least one SAE during the study.
Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.	up to 21 months, plus 24 hours after the end of study treatment	Number of participants with an increase in ALT and/or AST to \> 3 times upper limit of normal during the study.