Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OL

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2007-001741-18-IT
• Date of registration: 23/03/2009
• Prospective Registration: No
• Primary sponsor: Actelion Registration Ltd
• Public title: Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OL
• Scientific title: Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OL
• Date of first enrolment: 07/03/2008
• Target sample size: 390
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001741-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Before the release of the BUILD 3 results: Patients who have experienceda BUILD 3 protocol-defined event of IPF worsening and have had at least1 year of double-blind treatment in BUILD 3. If BUILD 3 shows positive results: all patients who have completedBUILD 3 have the option of entering this OL study within 2 months afterthe last visit in BUILD 3. Signed informed consent prior to initiation of any study-relatedprocedures. Women of childbearing potential must have a negative serum pregnancytest and use reliable methods of contraception during study treatment andfor 3 months after study treatment termination. Patients should have completed all the assessments from the BUILD 3EOS 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:
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 treatmentcompliance, study conduct or interpretation of the results, such as drug oralcohol dependence or psychiatric disease. Known hypersensitivity to bosentan or any of the excipients.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idipathic Pulmonary Fibrosis
MedDRA version: 9.1 Level: LLT Classification code 10001892 Term: Alveolitis fibrosing

Intervention(s)

Trade Name: TRACLEER
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bosentan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Primary end point(s): No primary endpoint is considered for this OL extension study.

Secondary Objective: - AEs leading to premature discontinuation of study drug.- Treatment-emergent SAEs and SAEs up to 28 days after the end of study drug treatment.- Occurrence of LFT (ALT and AST) abnormality (up to 24 hours after the end of study treatment): > 3 and ≤ 5 × ULN> 5 and ≤ 8 × ULN> 8 × ULN

Main Objective: To assess long-term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF) , who completed protocol AC-052-321 / BUILD 3.

Secondary ID(s)

2007-001741-18-FR

AC-052-322