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

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: February 12, 2008
Last updated: September 9, 2015
Last verified: March 2015
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).

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Bosentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Mean extent of exposure to bosentan treatment in months

Secondary Outcome Measures:
  • Number of Patients Exposed to Bosentan Over Time [ Time Frame: Start to end of study, up to 21 months ] [ Designated as safety issue: Yes ]
    Numbers of participants exposed to bosentan treatment over time

  • Adverse Events (AE) Leading to Discontinuation of Study Drug. [ Time Frame: Start to end of study, up to 21 months ] [ Designated as safety issue: Yes ]
    Number of participants with at least one AE that led to permanent discontinuation of study treatment.

  • Treatment-emergent Serious Adverse Events (SAE) [ Time Frame: up to 21 months plus 28 days after the end of study drug ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: up to 21 months, plus 24 hours after the end of study treatment ] [ Designated as safety issue: Yes ]
    Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.

Enrollment: 128
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.)

Other Name: Tracleer


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00631475

  Show 61 Study Locations
Sponsors and Collaborators
Study Chair: Isabelle Leconte Actelion
  More Information

No publications provided

Responsible Party: Actelion Identifier: NCT00631475     History of Changes
Other Study ID Numbers: AC-052-322
Study First Received: February 12, 2008
Results First Received: June 19, 2012
Last Updated: September 9, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Actelion:
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
BUILD 3 (NCT00391443)

Additional relevant MeSH terms:
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015