Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Actelion Idiopathic Pulmonary Fibrosis bosentan Tracleer Interstitial Lung Disease BUILD 3 (NCT00391443)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 128
Healthy volunteers: no

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 patients with idiopathic pulmonary fibrosis (IPF).

Detailed description:

Arms:
arm 1: 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

Interventions: intervention 1: Bosentan
Intervention descriptions: intervention 1: For patients who were administered Bosentan during BUILD 3 (NCT00391443):

continue on same dose

For patients who were administered placebo during BUILD 3 (NCT00391443):

Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs \< 90 lbs.)

Protocol document: