BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002900-40-AT

Enrollment

128

Registered

2005-11-07

Start date

2005-08-15

Completion date

Unknown

Last updated

2013-05-27

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

Conditions

Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Interventions

Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Patients having completed the 16-week treatment period of protocol AC-052-366/BENEFIT · Signed informed consent prior to initiation of any study-mandated procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · Any major violation of protocol AC-052-366/BENEFIT · Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The study objectives are to collect long-term efficacy, tolerability and safety data in patients with inoperable CTEPH treated with bosentan;Secondary Objective: ;Primary end point(s): Efficacy endpoints: · 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. · Change from baseline to all assessed time points in NYHA class. · Time to clinical worsening up to End-of-Study. Clinical worsening is defined as: o Death, or o Lung transplantation, or o Hospitalization for worsening of pulmonary hypertension. For patients who were in the placebo arm of the BENEFIT study, the study baseline values are the EOS values of BENEFIT, unless the patient is enrolled more than 4 weeks after this visit. In this latter case the baseline assessments are performed during the enrollment visit. For patients who were in the bosentan arm of the BENEFIT study, the study baseline values are the baseline values of BENEFIT. Safety and tolerability enddpoints: · Adverse event(s) leading to premature discontinuation of study medication. · Serious adverse events up to 28 days after study medication discontinuation. · Occurrence of liver function test (ALT and/or AST) abnormality (> 3 and 5 and 8 x ULN) and hemoglobin abnormality ( 8 and <= 10 g/dl)	—

Measure

Time frame

Main Objective: The study objectives are to collect long-term efficacy, tolerability and safety data in patients with inoperable CTEPH treated with bosentan;Secondary Objective: ;Primary end point(s): Efficacy endpoints: · 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. · Change from baseline to all assessed time points in NYHA class. · Time to clinical worsening up to End-of-Study. Clinical worsening is defined as: o Death, or o Lung transplantation, or o Hospitalization for worsening of pulmonary hypertension. For patients who were in the placebo arm of the BENEFIT study, the study baseline values are the EOS values of BENEFIT, unless the patient is enrolled more than 4 weeks after this visit. In this latter case the baseline assessments are performed during the enrollment visit. For patients who were in the bosentan arm of the BENEFIT study, the study baseline values are the baseline values of BENEFIT. Safety and tolerability enddpoints: · Adverse event(s) leading to premature discontinuation of study medication. · Serious adverse events up to 28 days after study medication discontinuation. · Occurrence of liver function test (ALT and/or AST) abnormality (> 3 and 5 and 8 x ULN) and hemoglobin abnormality ( 8 and <= 10 g/dl)

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Countries

Austria, Czech Republic, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026