NCT05179876

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Macitentan	Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (\>=) 2 year to less than (\<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.
DRUG	Selexipag	Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of \>=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight \< 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.
DRUG	Macitentan/Tadalafil FDC	Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.

Timeline

• Start date: 2022-05-04
• Primary completion: 2027-01-31
• Completion: 2028-02-29
• First posted: 2022-01-05
• Last updated: 2026-04-13

Locations

45 sites across 13 countries: Belarus, Belgium, Bulgaria, China, Hungary, Poland, Russia, South Africa, South Korea, Taiwan, Thailand, Ukraine, Vietnam