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

NCT00631475 | Completed Phase 3 Results

• 1 other identifier: AC-052-322
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Mean extent of exposure to bosentan treatment in months

  Start of study to end of study, up to 21 months

Secondary Outcomes (4)

• Number of Patients Exposed to Bosentan Over Time

  Start to end of study, up to 21 months

• Adverse Events (AE) Leading to Discontinuation of Study Drug.

  Start to end of study, up to 21 months

• Treatment-emergent Serious Adverse Events (SAE)

  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.

  up to 21 months, plus 24 hours after the end of study treatment

Study Arms (1)

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

Drug: Bosentan

Interventions

Bosentan DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Isabelle Leconte, PhD/Data Science Group Leader, Director
• Organization: Actelion Pharmaceuticals Ltd

isabelle.leconte@actelion.com

+ 41 61 565 64 18

Study Officials

• Isabelle Leconte

  Actelion

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: March 7, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 4, 2025
• Results First Posted: August 3, 2012

Record last verified: 2025-01