A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 58
- Locations
- 36
- Primary Endpoint
- Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
Study Overview
Brief Summary
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Months to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAH-progression, if bosentan was not permanently discontinued
- •Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of the FUTURE 3 core study (AC-052-373)
- •Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure.
Exclusion Criteria
- •Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible bosentan tablet
- •Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy
- •AST and/or ALT values > 3 times the upper limit of normal range (ULN)
- •Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
- •Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373)
- •Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
Arms & Interventions
bosentan 2mg/kg b.i.d.
Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
Intervention: Bosentan (Drug)
bosentan 2mg/kg t.i.d.
Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
Intervention: Bosentan (Drug)
Outcomes
Primary Outcomes
Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
Time Frame: Up to 62 weeks in average
This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study. NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.
Secondary Outcomes
No secondary outcomes reported