Phase 3
Completed N=128
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
Source: ClinicalTrials.gov NCT00631475 ↗Enrolled (actual)
128
Serious AEs
39.8%
Results posted
Aug 2012
Primary outcomePrimary: Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) — 6.4 months
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) |
6.4 | — |
| SECONDARY Number of Patients Exposed to Bosentan Over Time |
74; 44; 17; 7; 2 | — |
| SECONDARY Adverse Events (AE) Leading to Discontinuation of Study Drug. |
32 | — |
| SECONDARY Treatment-emergent Serious Adverse Events (SAE) |
51 | — |
| SECONDARY Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality. |
3 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00631475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.