A Clinical Study in France to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Arterial Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.

Study Purpose

The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) who were previously treated with macitentan in clinical studies.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed informed consent to take part in the study before any study mandated procedure. 2. Subjects currently treated with macitentan in a clinical study that is about to come to an end in France. 3. Women of childbearing potential are able to take part in the study if the following applies: 1. Urine pregnancy test is negative at Enrollment. 2. Agreement to perform monthly urine or serum pregnancy tests during the study and up to at least 30 days after the study treatment discontinuation. 3. Agreement to adhere to the planned contraception scheme from Enrollment up to at least 30 days after study treatment discontinuation.

Exclusion Criteria:

1. Hemoglobin less than 80 g/L. 2. Serum aspartate (AST) and/or alanine (ALT) aminotransferases more than three times the upper limit of normal range. 3. Known and documented history of severe drug-induced hepatic impairment (with or without cirrhosis). 4. Pregnant, planning to become pregnant, or breastfeeding. 5. Known hypersensitivity to macitentan, its excipients, or drugs of the same class. 6. Planned or current treatment with another investigational treatment up to 3 months prior to Enrollment. 7. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03422328
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Actelion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Thomas Pfister, PhD
Principal Investigator Affiliation Actelion
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Belarus, France, Poland, Ukraine
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Additional Details

The purpose of this study is to provide continued treatment with macitentan to subjects with PAH who participated or participate in "parent studies" in France and to continue to accrue long-term safety data. "Parent study/studies" refer to a number of clinical studies with macitentan that are conducted in different clinical classification of PAH (NCT00667823, NCT02112487, NCT02310672, NCT02968901, NCT02558231) and may be completed before the participating subjects have access to commercial macitentan in their country of residence. The "parent studies" are fully or partially running in France where no access to commercial macitentan is expected in the near future.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Lviv, Ukraine

Status

Address

DANYLO GALYTSKIY LVIV - INTERNAL MEDICINE (Lviv)

Lviv, , 79010

DNIPROPETROVSK MEDICAL ACADEMY (Dnipro), Dnipro, Ukraine

Status

Address

DNIPROPETROVSK MEDICAL ACADEMY (Dnipro)

Dnipro, , 49070

CARDIOLOGY ZABRZE UNIV (Zabrze), Zabrze, Poland

Status

Address

CARDIOLOGY ZABRZE UNIV (Zabrze)

Zabrze, , 41-800

Otwock, Poland

Status

Address

CARDIOLOGY OTWOCK PRIV - EUROPEAN HEALTH CENTRE OTWOCK (Otwock)

Otwock, , 05-400

CARDIOLOGY KRAKÓW (Krakow), Krakow, Poland

Status

Address

CARDIOLOGY KRAKÓW (Krakow)

Krakow, , 31-202

CHU de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy, France

Status

Address

CHU de Nancy, Hôpitaux de Brabois

Vandoeuvre Les Nancy, , 54511

CHU de Toulouse, Hôpital Larrey, Toulouse, France

Status

Address

CHU de Toulouse, Hôpital Larrey

Toulouse, , 31059

CHRU de Strasbourg, Hôpital Civil, Strasbourg, France

Status

Address

CHRU de Strasbourg, Hôpital Civil

Strasbourg, , 67091

CHU de Saint-Etienne, Hôpital Nord, Saint-Etienne, France

Status

Address

CHU de Saint-Etienne, Hôpital Nord

Saint-Etienne, , 42000

Rouen, France

Status

Address

CHU de Rouen Normandie, Hôpital Charles Nicolle

Rouen, , 76031

CHU de Rennes, Hôpital Pontchaillou, Rennes, France

Status

Address

CHU de Rennes, Hôpital Pontchaillou

Rennes, , 35033

CHU de Reims, Reims, France

Status

Address

CHU de Reims

Reims, , 51100

CHU de Nice, Hôpital Pasteur, Nice, France

Status

Address

CHU de Nice, Hôpital Pasteur

Nice, , 06001

CHU de Nantes, Hôpital Nord Laennec, Nantes, France

Status

Address

CHU de Nantes, Hôpital Nord Laennec

Nantes, , 44093

Montpellier, France

Status

Address

CHU de Montpellier, Hôpital Arnaud de Villeneuve

Montpellier, , 34295

CHU de la Timone, Marseille, France

Status

Address

CHU de la Timone

Marseille, , 13385

HCL, Hôpital Louis Pradel, Lyon, France

Status

Address

HCL, Hôpital Louis Pradel

Lyon, , 69667

CHU de Limoges - Hôpital Dupuytren 2, Limoges, France

Status

Address

CHU de Limoges - Hôpital Dupuytren 2

Limoges, , 87042

CHRU de Lille, Hôpital cardiologique, Lille, France

Status

Address

CHRU de Lille, Hôpital cardiologique

Lille, , 59037

Le Kremlin-Bicêtre, France

Status

Address

Service de pneumologie et Réanimation Respiratoire, CHU de Bicêtre

Le Kremlin-Bicêtre, , 94275

Grenoble, France

Status

Address

CHU de Grenoble, Clinique Univ Pneumo Pôle Thorax et Vaisseaux

Grenoble, , 38700

CHU de Dijon, Dijon, France

Status

Address

CHU de Dijon

Dijon, , 21079

CHU de la Côte de Nacre, Caen, France

Status

Address

CHU de la Côte de Nacre

Caen, , 14033

CHU de la Cavale Blanche, Brest, France

Status

Address

CHU de la Cavale Blanche

Brest, , 29609

CHU de Bordeaux, Hôpital de Haut Levêque, Bordeaux, France

Status

Address

CHU de Bordeaux, Hôpital de Haut Levêque

Bordeaux, , 33604

CHRU de Besançon, Hôpital Jean Minjoz, Besançon, France

Status

Address

CHRU de Besançon, Hôpital Jean Minjoz

Besançon, , 25030

Minsk, Belarus

Status

Address

The Republican Scientific-Practical Center "Cardiology"

Minsk, , 220036

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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