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OpenTrials
Completed

NCT Number: NCT00319033

Open-label Study With Bosentan in Interstitial Lung Disease

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

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Key information

Conditions

Interstitial Lung Disease Connective Tissue Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosentan

Drug

Primary outcomes

  1. Change from baseline to all assessed time points in 6-minute walk test distance.

  2. 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).

  3. Transition Dyspnea Index at all assessed time points.

  4. 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 outcomes

  1. Adverse events; serious adverse events.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

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

Acronym: BUILD 2 OL

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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