ACT-385781A for PAH pediatric patients

Prospectiove, single-arm, Open-label, multi-center study to assess the efficacy, safety, and tolerability of ACT-385781A in Japanese children with pulmonary arterial hypertension.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222670

Enrollment

Registered

2014-11-27

Start date

2014-11-27

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Pulmonary arterial hypertension (PAH)

Interventions

investigational material(s) Generic name etc : ACT-385781A INN of investigational material : epoprostenol Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Idiopathic PAH, Heritable PAH, PAH associated with CHD

Exclusion criteria

Exclusion criteria: Patients with respiratory and/or cardiovascular distress in need of emergency care, etc.

Design outcomes

Primary

Measure	Time frame
Changes in cardiopulmonary hemodynamics (PVRI) from baseline to week 12 of treatment. RHC	—

Secondary

Measure	Time frame
To evaluate other hemodynamic variables, NT-pro BNP, WHO functional class , Global Clinical Impression scale, safety and tolerability. RHC, Blood samples, etc.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026