Overview

An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.

Status:
Active, not recruiting

Trial end date:
2022-01-17

Target enrollment:

Participant gender:

Summary

The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.

Phase:

Phase 3

Details

Lead Sponsor:

Actelion

Collaborators:

ActiGraph LLC
Almac Clinical Technologies
Covance
Henry Ford Health System
Medidata Solutions

Treatments:

Macitentan