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

Primary Purpose

Interstitial Lung Disease, Scleroderma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bosentan
Sponsored by
Actelion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Lung Disease focused on measuring interstitial lung disease, scleroderma, bosentan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Alabama
  • UCLA Med School
  • Denver Health Medical Center
  • Georgetown University
  • Jackson Memorial Hospital
  • University of Illinois College of Medicine
  • University of Michigan Health System - Division of Pulmonary & Critical Care Medicine
  • UMDNJ
  • Lee Shapiro, MD
  • The Cleveland Clinic
  • Thomas Jefferson University
  • Medical Univ of South Carolina
  • Medical University of South Carolina
  • Maureen Mayes, MD
  • Virginia Mason Medical Center
  • University of Washington - Division of Pulmonary & Critical Care Medicine
  • Eric Rich, MD
  • Centre Hospitalier Universitaire
  • CHRU Claude Huriez
  • Hôpital Cochin
  • Hôpital Saint Antoine
  • Charité Universitätsklinikum
  • Rabin Medical Center
  • Instituto di Clinica, Villa Monna Tessa
  • Ospedale Maggiore
  • Policlinico Universitario
  • SoonChunHyang University Bucheon Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • 7003 - Asan Medical Center
  • Samsung Medical Center
  • Sint Maartenskliniek
  • University Hospital
  • University Hospital
  • General Infirmary
  • Royal Free Hospital

Outcomes

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.

Full Information

First Posted
April 26, 2006
Last Updated
April 28, 2015
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00319033
Brief Title
Open-label Study With Bosentan in Interstitial Lung Disease
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Actelion

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Scleroderma
Keywords
interstitial lung disease, scleroderma, bosentan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bosentan
Primary Outcome Measure Information:
Title
Change from baseline to all assessed time points in 6-minute walk test distance.
Title
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).
Title
Transition Dyspnea Index at all assessed time points.
Title
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 Measure Information:
Title
Adverse events; serious adverse events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCLA Med School
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Illinois College of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Michigan Health System - Division of Pulmonary & Critical Care Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
UMDNJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Lee Shapiro, MD
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Medical Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Maureen Mayes, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington - Division of Pulmonary & Critical Care Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Eric Rich, MD
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Centre Hospitalier Universitaire
City
Grenoble
Country
France
Facility Name
CHRU Claude Huriez
City
Lille
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
Country
France
Facility Name
Charité Universitätsklinikum
City
Berlin
Country
Germany
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Instituto di Clinica, Villa Monna Tessa
City
Firenze
Country
Italy
Facility Name
Ospedale Maggiore
City
Milano
Country
Italy
Facility Name
Policlinico Universitario
City
Padova
Country
Italy
Facility Name
SoonChunHyang University Bucheon Hospital
City
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
7003 - Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Sint Maartenskliniek
City
Nijmegen
Country
Netherlands
Facility Name
University Hospital
City
Lund
Country
Sweden
Facility Name
University Hospital
City
Zurich
Country
Switzerland
Facility Name
General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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Open-label Study With Bosentan in Interstitial Lung Disease

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