Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443 (BUILD OL)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Bosentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631475

AC-052-322

Details and patient eligibility

About

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).

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: Bosentan