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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

February 12, 2008
September 27, 2012
April 2008
April 2010   (final data collection date for primary outcome measure)
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
There is no primary outcome measure for this OL study [ Time Frame: There is no primary outcome measure for this OL study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00631475 on ClinicalTrials.gov Archive Site
  • 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.
  • AE's leading to discontinuation of study drug [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
  • Treatment-emergent SAE's [ Time Frame: up to 28 days after the end of study drug ] [ Designated as safety issue: Yes ]
  • Occurrence of LFT (ALT and AST) abnormality [ Time Frame: up to 24 hours after the end of study treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
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
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

Intervention: Drug: Bosentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
May 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Spain,   Switzerland,   United Kingdom
 
NCT00631475
AC-052-322
No
Actelion
Actelion
Not Provided
Study Chair: Isabelle Leconte Actelion
Actelion
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP