The Extension of the research project FUTURE 4 to find out whether patients with persistent pulmonary hypertension of the newborn (PPHN) who received bosentan in addition to inhaled nitric oxide grow normally and to study whether they have late side effects.

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001829-27-BE

Enrollment

Registered

2013-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Persistent Pulmonary Hypertension of the Newborn (PPHN) MedDRA version: 14.1 Level: LLT Classification code 10053592 Term: Newborn persistent pulmonary hypertension System Organ Class: 100000004850

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent by the parent(s) or the legal representative(s). 2. At least one dose of study drug received in FUTURE 4 (AC-052-391). Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients for whom informed consent cannot be obtained within 6 months after approval of Protocol Version 3 at the respective study site.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess long-term safety and effects on growth in patients who received bosentan or placebo for a maximum of 14 days as adjunctive therapy to inhaled nitric oxide (iNO) for persistent pulmonary hypertension of the newborn (PPHN) in study FUTURE 4 (AC-052-391).;Secondary Objective: none;Primary end point(s): Safety and Growth Endpoints: - SAEs occurring more than 60 days after the End-of-Treatment (EoT) in the FUTURE 4 study (AC-052-391) and up to End-of-Observation-Period (EoOP). - Non-serious adverse events (AEs) occurring during the observation period (i.e., from EoS in FUTURE 4 [AC-052-391] up to EoOP). - Change from baseline to EoOP in growth variables (i.e., weight and length).;Timepoint(s) of evaluation of this end point: see above	—

Measure

Time frame

Main Objective: To assess long-term safety and effects on growth in patients who received bosentan or placebo for a maximum of 14 days as adjunctive therapy to inhaled nitric oxide (iNO) for persistent pulmonary hypertension of the newborn (PPHN) in study FUTURE 4 (AC-052-391).;Secondary Objective: none;Primary end point(s): Safety and Growth Endpoints: - SAEs occurring more than 60 days after the End-of-Treatment (EoT) in the FUTURE 4 study (AC-052-391) and up to End-of-Observation-Period (EoOP). - Non-serious adverse events (AEs) occurring during the observation period (i.e., from EoS in FUTURE 4 [AC-052-391] up to EoOP). - Change from baseline to EoOP in growth variables (i.e., weight and length).;Timepoint(s) of evaluation of this end point: see above

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Belgium, Czech Republic, France, Korea, Republic of, Poland, Russian Federation, Singapore, United Kingdom, United States

Contacts

Public ContactGLOBAL MEDICAL INFORMATION

Actelion Pharmaceuticals Ltd.

medinfo@actelion.com

Outcome results

None listed

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