Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1 Level: LLT Classification code 10021240 Term: Idiopathic pulmonary fibrosis
Conditions
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Before the release of the BUILD 3 results: Patients who have experienced a BUILD 3 protocol-defined event of IPF worsening and have had at least 1 year of double-blind treatment in BUILD 3. •If BUILD 3 shows positive results: all patients who have completed BUILD 3 have the option of entering this OL study within 2 months after the last visit in BUILD 3. •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. •Patients should have completed all the assessments from the BUILD 3 EOS visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Any major violation of protocol AC-052-321 / BUILD 3. •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).;Secondary Objective: ;Primary end point(s): N/A | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed