FUTURE 4 Non-drug-interventional extension study
Research type
Research Study
Full title
Multi-center non-drug-interventional extension study to assess long-term safety and effects on growth in patients who received bosentan or placebo as adjunctive therapy to inhaled nitric oxide for persistent pulmonary hypertension of the newborn in FUTURE 4(AC-052-391)
IRAS ID
112413
Contact name
Christine Pierce
Contact email
Eudract number
2012-001829-27
Research summary
This is a multi-centre, non-drug-interventional, exploratory, Phase III extension study to the FUTURE 4 study. Patients who participated in the FUTURE 4 (AC-052-391) study and who received at least one dose of study drug (bosentan or placebo) will be enrolled, subject to consent being provided by the parent or legal representative.
The purpose of this study is to monitor the health of babies during the first year of life, in babies who received short-term bosentan or placebo for the treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN).
The study will be undertaken at centres participating in the FUTURE 4 (AC-052-391) study and the maximum number of patients to be enrolled corresponds to the number of patients who received at least one dose of study drug in the FUTURE 4 study.
No study drug will be administered during this extension study and the Sponsor and investigator will remain blinded to the study treatment of individual patients (placebo or bosentan) until after the closure of the FUTURE 4 (AC-052-391) database.
Patients enrolled into this extension study will be observed from the end of study (EoS) of the FUTURE 4 (AC-052-391) study until the End of Observation Period (EoOP) for this extension study.
Study assessments include the collection of safety data (adverse events [AE’s] and Serious Adverse Events [SAE’s]) and health assessments (body weight and length). Details of any administration of commercial bosentan treatment (Tracleer® ) during the observation period will also be collected.
Study assessments will be performed at Enrollment, Month 4, Month 8 and Month 12-14 after end of study (EoS) for the FUTURE 4 (AC-052-391) study. If study enrollment occurs after the time window for the scheduled contacts, the contacts become non-applicable and the data will be collected retrospectively.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1571
Date of REC Opinion
30 Oct 2013
REC opinion
Favourable Opinion