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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00631475
• Date of registration: 12/02/2008
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443 BUILD OL
• Scientific title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
• Date of first enrolment: April 2008
• Target sample size: 128
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00631475
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Former Serbia and Montenegro, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Serbia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Isabelle Leconte
• Affiliation: Actelion

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Bosentan

Primary Outcome(s)

Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) [Time Frame: Start of study to end of study, up to 21 months]

Secondary Outcome(s)

Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality. [Time Frame: up to 21 months, plus 24 hours after the end of study treatment]

Adverse Events (AE) Leading to Discontinuation of Study Drug. [Time Frame: Start to end of study, up to 21 months]

Number of Patients Exposed to Bosentan Over Time [Time Frame: Start to end of study, up to 21 months]

Treatment-emergent Serious Adverse Events (SAE) [Time Frame: up to 21 months plus 28 days after the end of study drug]

Secondary ID(s)

AC-052-322

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00631475