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

NCT03775421 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-03-07

Study results available
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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 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.

Conditions

  • Congenital Heart Disease With Fontan Circulation

Interventions

DRUG

macitentan 10 mg

macitentan 10 mg, film-coated tablet, oral use

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Henry Ford Health System

    collaborator OTHER

  • Almac Clinical Technologies

    collaborator INDUSTRY

  • ActiGraph LLC

    collaborator OTHER

  • Medidata Solutions

    collaborator INDUSTRY

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Thierry Francis Briand, MD · Actelion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2022-01-18
Completion
2022-01-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • New Zealand
  • Poland
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775421 on ClinicalTrials.gov