Status:
COMPLETED
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
Lead Sponsor:
Actelion
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00631475
Start Date
April 1 2008
End Date
May 1 2010
Last Update
February 4 2025
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