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

April 28, 2015 updated by: Actelion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

132

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Eric Rich, MD
  • France
      • Grenoble, France
        • Centre Hospitalier Universitaire
      • Lille, France
        • CHRU Claude Huriez
      • Paris, France
        • Hopital Saint Antoine
      • Paris, France
        • Hôpital COCHIN
  • Germany
      • Berlin, Germany
        • Charité Universitätsklinikum
  • Israel
      • Petach Tikva, Israel
        • Rabin Medical Center
  • Italy
      • Firenze, Italy
        • Instituto di Clinica, Villa Monna Tessa
      • Milano, Italy
        • Ospedale Maggiore
      • Padova, Italy
        • Policlinico Universitario
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 420-767
        • Soonchunhyang University Bucheon Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • 7003 - Asan Medical Center
  • Netherlands
      • Nijmegen, Netherlands
        • Sint Maartenskliniek
  • Sweden
      • Lund, Sweden
        • University Hospital
  • Switzerland
      • Zurich, Switzerland
        • University Hospital
  • United Kingdom
      • Leeds, United Kingdom
        • General Infirmary
      • London, United Kingdom
        • Royal Free Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University Of Alabama
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Med School
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois College of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System - Division of Pulmonary & Critical Care Medicine
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ
    • New York
      • Albany, New York, United States, 12206
        • Lee Shapiro, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19004
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Univ of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • Maureen Mayes, MD
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195
        • University of Washington - Division of Pulmonary & Critical Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Adverse events; serious adverse events.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

February 1, 2006

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

April 26, 2006

First Submitted That Met QC Criteria

April 26, 2006

First Posted (ESTIMATE)

April 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-052-332
  • BUILD 2 OL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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