Status:
TERMINATED
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
Lead Sponsor:
Actelion
Collaborating Sponsors:
Covance
Henry Ford Health System
Conditions:
Congenital Heart Disease With Fontan Circulation
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 RUB...
Eligibility Criteria
Inclusion
- Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures.
- Subjects who have completed Week 52 of the parent AC-055H301/RUBATO DB study (NCT03153137)
- Women of childbearing potential must:
- have a negative serum pregnancy test prior to first intake of OL study drug, and,
- agree to perform monthly pregnancy tests up to the end of the safety follow up (S-FU) period, and,
- use reliable methods of contraception from enrollment up to at least 30 days after study treatment discontinuation.
Exclusion
- Clinical worsening leading to medical interventions including reoperation of Fontan circulation (Fontan take-down) during the enrollment period
- Systolic blood pressure \< 90 mmHg (\< 85 mmHg for subjects \< 18 years old and \< 150 cm of height) at rest
- Criteria related to macitentan use
- Any known factor or disease that may interfere with treatment compliance or full participation in the study
Key Trial Info
Start Date :
April 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03775421
Start Date
April 11 2019
End Date
January 18 2022
Last Update
March 7 2023
Active Locations (19)
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1
Massachusetts General Hospital Heart Center
Boston, Massachusetts, United States, 02114
2
Providence Medical Research Providence Health Care
Spokane, Washington, United States, 99202
3
Royal Adelaide Hospital
Adelaide, Australia, 5000
4
Royal Prince Alfred Hospital
Camperdown, Australia, 2050