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

Stopped early · Phase 3

Conditions studied: Congenital Heart Disease With Fontan Circulation

In brief

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.

Key facts

Study ID

NCT03775421

Run by

Actelion

People needed

112

Starts

2019-04-11

Expected to finish

2022-01-18

Last updated by the study team

2023-03-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital Heart Center — Boston, Massachusetts, United States
• Providence Medical Research Providence Health Care — Spokane, Washington, United States
• Royal Adelaide Hospital — Adelaide, Australia
• Royal Prince Alfred Hospital — Camperdown, Australia
• The Prince Charles Hospital, Adult Congenital Heart Disease Unit — Chermside, Australia
• Royal Children's Hospital — Parkville, Australia
• CHU de Québec Université Laval — Québec, Quebec, Canada
• Beijing Anzhen Hospital — Beijing, China
• Shanghai Children's Medical Center — Shanghai, China
• Fakultni nemocnice v Motole — Prague, Czechia
• Rigshospitalet Kardiologisk Klinisk — Copenhagen, Denmark
• Hôpital Necker - Enfants Malades — Paris, France
• Hôpital Cardiologique Du Haut-Lévêque — Pessac, France
• Auckland City Hospital — Auckland, New Zealand
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn — Krakow, Poland
• Wojewodzki Szpital Specjalistyczny We Wroclawiu — Wroclaw, Poland
• National Taiwan University Hospital — Taipei, Taiwan
• Queen Elizabeth Hospital — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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