EUCTR2018-002821-45-DEActive, not recruitingPhase 1
Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO O
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Actelion Pharmaceuticals Ltd
- Enrollment
- 111
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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