BUILD 2 OL: Open-label Study With Bosentan in Interstitial Lung Disease

Sponsor

Actelion (Industry)

Overall Status

Completed

CT.gov ID

NCT00319033

Collaborator

(none)

132

Enrollment

Locations

19.1

Duration (Months)

3.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease Scleroderma	Drug: bosentan	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

Change from baseline to all assessed time points in 6-minute walk test distance. []
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). []
Transition Dyspnea Index at all assessed time points. []
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 Outcome Measures

Adverse events; serious adverse events. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	UCLA Med School	Los Angeles	California	United States	90095
3	Denver Health Medical Center	Denver	Colorado	United States	80204
4	Georgetown University	Washington	District of Columbia	United States	20007
5	Jackson Memorial Hospital	Miami	Florida	United States	33136
6	University of Illinois College of Medicine	Chicago	Illinois	United States	60612
7	University of Michigan Health System - Division of Pulmonary & Critical Care Medicine	Ann Arbor	Michigan	United States	48109
8	UMDNJ	New Brunswick	New Jersey	United States	08903
9	Lee Shapiro, MD	Albany	New York	United States	12206
10	The Cleveland Clinic	Cleveland	Ohio	United States	44195
11	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19004
12	Medical Univ of South Carolina	Charleston	South Carolina	United States	29425
13	Medical University of South Carolina	Charleston	South Carolina	United States	29425
14	Maureen Mayes, MD	Houston	Texas	United States	77030
15	Virginia Mason Medical Center	Seattle	Washington	United States	98101
16	University of Washington - Division of Pulmonary & Critical Care Medicine	Seattle	Washington	United States	98195
17	Eric Rich, MD	Montreal	Quebec	Canada	H2L 4M1
18	Centre Hospitalier Universitaire	Grenoble		France
19	CHRU Claude Huriez	Lille		France
20	Hôpital Cochin	Paris		France
21	Hôpital Saint Antoine	Paris		France
22	Charité Universitätsklinikum	Berlin		Germany
23	Rabin Medical Center	Petach Tikva		Israel
24	Instituto di Clinica, Villa Monna Tessa	Firenze		Italy
25	Ospedale Maggiore	Milano		Italy
26	Policlinico Universitario	Padova		Italy
27	SoonChunHyang University Bucheon Hospital	Gyeonggi-do		Korea, Republic of	420-767
28	Gachon University Gil Medical Center	Incheon		Korea, Republic of
29	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
30	7003 - Asan Medical Center	Seoul		Korea, Republic of	138-736
31	Samsung Medical Center	Seoul		Korea, Republic of
32	Sint Maartenskliniek	Nijmegen		Netherlands
33	University Hospital	Lund		Sweden
34	University Hospital	Zurich		Switzerland
35	General Infirmary	Leeds		United Kingdom
36	Royal Free Hospital	London		United Kingdom