Open-label Study With Bosentan in Interstitial Lung Disease

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00319033

Acronym

BUILD 2 OL

Enrollment

132

Registered

2006-04-27

Start date

2004-07-31

Completion date

2006-02-28

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease, Scleroderma

Keywords

interstitial lung disease, scleroderma, bosentan

Brief summary

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

Interventions

DRUGbosentan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse events; serious adverse events.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026