Status and phase
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About
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.
Enrollment
Sex
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Volunteers
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 the parent AC-055H301/RUBATO DB study (NCT03153137)
Women of childbearing potential must:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
112 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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