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

Actelion128 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

BosentanDRUG

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.)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Mean extent of exposure to bosentan treatment in months

Time frame: Start of study to end of study, up to 21 months

Secondary Outcomes

Number of Patients Exposed to Bosentan Over Time

Numbers of participants exposed to bosentan treatment over time

Time frame: Start to end of study, up to 21 months

Adverse Events (AE) Leading to Discontinuation of Study Drug.

Number of participants with at least one AE that led to permanent discontinuation of study treatment.

Time frame: Start to end of study, up to 21 months

Treatment-emergent Serious Adverse Events (SAE)

Number of participants with at least one SAE during the study.

Time frame: up to 21 months plus 28 days after the end of study drug

Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.

Number of participants with an increase in ALT and/or AST to \> 3 times upper limit of normal during the study.

Time frame: up to 21 months, plus 24 hours after the end of study treatment

Data from ClinicalTrials.gov

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