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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.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00631475
First received: February 12, 2008
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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:

Drug Information available for: Bosentan
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631475

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

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov 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 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
 Lung Diseases, Interstitial
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013