An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients

Phase 1

• Conditions: Congenital Heart Failure; MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 21.1Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-002821-45-DE
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-27
• Study Completion: 2022-01-18
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

. 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 AC-055H301 RUBATO DB.
. 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified