Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

Last updated: March 28, 2025
Sponsor: Actelion
Overall Status: Completed

Phase

3

Condition

Congenital Heart Disease

Pentalogy Of Cantrell

Heart Disease

Treatment

Macitentan 10 mg

Placebo

Clinical Study ID

NCT03153137
AC-055H301
2016-003320-23
  • Ages > 12
  • All Genders

Study Summary

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent/assent from the subject and/or a legal representative priorto initiation of any study-mandated procedures

  • Fontan-palliated subjects with either intra-atrial lateral tunnel totalcavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary toatrio-pulmonary connection

  • New York Heart Association (NYHA) functional class (FC) II or III (assessed by theinvestigator using the Specific Activity Scale

  • Women of childbearing potential must have a negative serum pregnancy test usereliable contraception

Exclusion

Exclusion Criteria:

  • Pattern of Fontan circulation severity

  • Deterioration of the Fontan-palliated condition.

  • Limitations to Cardiopulmonary exercise testing (CPET)

  • Peak VO2 < 15 mL/kg/min.

  • Any known factor or disease that may interfere with treatment compliance or fullparticipation in the study

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: Macitentan 10 mg
Phase: 3
Study Start date:
August 14, 2017
Estimated Completion Date:
July 26, 2021

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, 2050
    Australia

    Site Not Available

  • The Prince Charles Hospital, Adult Congenital Heart Disease Unit

    Chermside, 4032
    Australia

    Site Not Available

  • Royal Children's Hospital

    Parkville, 3052
    Australia

    Site Not Available

  • Queensland CHILDREN'S HOSPITAL

    South Brisbane, 4101
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, 2145
    Australia

    Site Not Available

  • Hospital Pequeno Principe

    Curitiba, 80250-060
    Brazil

    Site Not Available

  • Hospital de Messejana dr. Carlos Alberto Studart Gomes

    Fortaleza, 60840-285
    Brazil

    Site Not Available

  • Fundacao Universitaria de Cardiologia

    Porto Alegre, 90620-001
    Brazil

    Site Not Available

  • Irmandade Da Santa Casa de Misericordia de Sao Paulo

    Sao Paulo, 01221-020
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Centre Hospitalier Sainte Justine

    Montreal, Quebec H3T 1C4
    Canada

    Site Not Available

  • CHU de Quebec Universite Laval

    Quebec, G1V 4G2
    Canada

    Site Not Available

  • CHU de Québec Université Laval

    Quebec, G1V 4G2
    Canada

    Site Not Available

  • Beijing Anzhen Hospital

    Beijing, 100029
    China

    Site Not Available

  • Beijing Fuwai Hospital

    Beijing, 100037
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • Shanghai Children's Medical Center

    Shanghai, 200127
    China

    Site Not Available

  • Shanghai Childrens Medical Center

    Shanghai, 200127
    China

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan, 430022
    China

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Rigshospitalet Kardiologisk Klinisk

    Copenhagen, 2100
    Denmark

    Site Not Available

  • CHU Arnaud de Villeneuve

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Hôpital Necker - Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Hôpital Cardiologique Du Haut-Lévêque

    Pessac, 33604
    France

    Site Not Available

  • Deutsches Herzzentrum Berlinklinik Für Angeborene Herzfehler

    Berlin, 13353
    Germany

    Site Not Available

  • Deutsches Herzzentrum München

    München, 80636
    Germany

    Site Not Available

  • Our Lady's Children's Hospital

    Dublin,
    Ireland

    Site Not Available

  • Auckland City Hospital

    Auckland, 1640
    New Zealand

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 952
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, 80-952
    Poland

    Site Not Available

  • Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn

    Krakow, 31 202
    Poland

    Site Not Available

  • Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

    Krakow, 31-202
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30-663
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Kraków, 30-663
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny We Wroclawiu

    Wroclaw, 51 124
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Kardiologii Dzieciecej z Pododdzialem Intensywnej Opieki Medycznej

    Wroclaw, 51124
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny We Wrocławiu

    Wrocław, 51-124
    Poland

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233-1935
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Congenital Heart Center of the University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Advocate Children's Hospital

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • University of Iowa Hospital

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Maryland Hospital

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital Heart Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Nebraska Medical Center & Childrens Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • The Pennsylvania State University College Of Medicine

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030-2303
    United States

    Site Not Available

  • University of Utah Primary Childrens Medical Center

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Providence Medical Research Providence Health Care

    Spokane, Washington 99202
    United States

    Site Not Available

  • Childrens Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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