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

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Scleroderma; Interstitial Lung Disease

Treatments: Drug: bosentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319033

BUILD 2 OL

AC-052-332

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)