Open-label Study With Bosentan in Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

— BUILD 2 OL  

Official title:

Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319033
• Other study ID #: AC-052-332
• Secondary ID: BUILD 2 OL
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 26, 2006
• Last updated: April 28, 2015
• Start date: July 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2015
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To have completed the 12-month treatment period of the AC-052-330/BUILD 2.

• Women should not be pregnant

• Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception

• Signed informed consent prior to initiation of any study-mandated procedure

Exclusion Criteria:

• Any major violation of the protocol AC-052-330.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Drug:
• bosentan

Locations

Country	Name	City	State
Canada	Eric Rich, MD	Montreal	Quebec
France	Centre Hospitalier Universitaire	Grenoble
France	CHRU Claude Huriez	Lille
France	Hôpital Cochin	Paris
France	Hôpital Saint Antoine	Paris
Germany	Charité Universitätsklinikum	Berlin
Israel	Rabin Medical Center	Petach Tikva
Italy	Instituto di Clinica, Villa Monna Tessa	Firenze
Italy	Ospedale Maggiore	Milano
Italy	Policlinico Universitario	Padova
Korea, Republic of	SoonChunHyang University Bucheon Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	7003 - Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Netherlands	Sint Maartenskliniek	Nijmegen
Sweden	University Hospital	Lund
Switzerland	University Hospital	Zurich
United Kingdom	General Infirmary	Leeds
United Kingdom	Royal Free Hospital	London
United States	Lee Shapiro, MD	Albany	New York
United States	University of Michigan Health System - Division of Pulmonary & Critical Care Medicine	Ann Arbor	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	Medical Univ of South Carolina	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Illinois College of Medicine	Chicago	Illinois
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Denver Health Medical Center	Denver	Colorado
United States	Maureen Mayes, MD	Houston	Texas
United States	UCLA Med School	Los Angeles	California
United States	Jackson Memorial Hospital	Miami	Florida
United States	UMDNJ	New Brunswick	New Jersey
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Washington - Division of Pulmonary & Critical Care Medicine	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to all assessed time points in 6-minute walk test distance.
Primary	Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value).
Primary	Transition Dyspnea Index at all assessed time points.
Primary	Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 = 4%), trough SpO2 and area under the curve during 6-minute walk test.
Secondary	Adverse events; serious adverse events.