A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary 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) and Chronic thromboembolic pulmonary hypertension (CTEPH) 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 N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed informed consent to take part in the study before any study mandated procedure. 2. Participants from one of the parent studies and: a) the sponsor has decided to terminate the parent study in that country and b) the participant has completed the end of treatment (EOT) Visit of the parent study. 3. Women of childbearing potential are able to take part in the study if the following applies: a) Urine pregnancy test is negative at Enrollment; b) Agreement to perform monthly urine or serum pregnancy tests during the study and up to at least 30 days after the study treatment discontinuation; and c) 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 gram per liter (g/L) 2. Serum Aspartate aminotransferase (AST) and/or alanine aminotransferases (ALT) more than three times the upper limit of normal range. 3. Known and documented history of severe hepatic impairment that is Child-Pugh Class C. 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. 8. Treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)

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, Ukraine
Conditions

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

Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Study Website: View Trial Website
Additional Details

The purpose of this study is to provide continued treatment with macitentan to subjects with PAH or CTEPH who participated in "parent studies" and to continue to accrue long-term safety data. The design of this study is widely used in clinical programs to give participants in a clinical study access to an effective study treatment beyond completion of the parent study. This is considered the best option to collect long-term safety and tolerability information of macitentan 10 mg and survival status of participants with PAH and CTEPH. "Parent study/studies" refer to a number of clinical studies with macitentan that are conducted in different clinical classification of PAH and CTEPH (NCT00667823, NCT02112487, NCT02310672, NCT02968901, NCT02558231, NCT02382016, NCT02060721) and may be completed before the participants have access to commercial macitentan in their country of residence. The "parent studies" are fully or partially running in countries where no access to commercial macitentan is expected in the near future.

Arms & Interventions

Arms

Experimental: Open-label macitentan 10 mg

10 mg macitentan film coated tablet, administered orally once daily

Interventions

Drug: - macitentan

macitentan 10 mg, film-coated tablet, oral use

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

Minsk, Belarus

Status

Address

Minsk Regional Clinical Hospital Of The Red Banner Of Labor

Minsk, ,

CHRU Besançon -Hôpital Jean Minjoz, Besançon, France

Status

Address

CHRU Besançon -Hôpital Jean Minjoz

Besançon, , 25030

CHU de Bordeaux - Hôpital Haut-Lévêque, Bordeaux (Pessac), France

Status

Address

CHU de Bordeaux - Hôpital Haut-Lévêque

Bordeaux (Pessac), , 33604

CHU de la Cavale Blanche, Brest Cedex 2, France

Status

Address

CHU de la Cavale Blanche

Brest Cedex 2, , 29609

Bron Cedex, France

Status

Address

GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

Bron Cedex, , 69677

Hôpital Côte de Nacre, Caen Cedex, France

Status

Address

Hôpital Côte de Nacre

Caen Cedex, ,

CHU Dijon, Dijon Cedex, France

Status

Address

CHU Dijon

Dijon Cedex, , 21079

CHU Grenoble, Grenoble, France

Status

Address

CHU Grenoble

Grenoble, , 38700

Le Kremlin Bicetre cedex, France

Status

Address

Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

Le Kremlin Bicetre cedex, , 94275

Hôpital Cardiologique - Chru Lille, Lille Cedex, France

Status

Address

Hôpital Cardiologique - Chru Lille

Lille Cedex, , 59037

CHU de Limoges, Limoges Cedex, France

Status

Address

CHU de Limoges

Limoges Cedex, , 87042

CHU de la Timone, Marseille cedex 5, France

Status

Address

CHU de la Timone

Marseille cedex 5, , 13385

Montpellier, France

Status

Address

CHU de Montpellier - Arnaud de Villeneuve

Montpellier, , 34295

CHU Nantes - Hopital Nord Laënnec, Nantes Cedex 1, France

Status

Address

CHU Nantes - Hopital Nord Laënnec

Nantes Cedex 1, , 44093

Nice, France

Status

Address

Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

Nice, , 06001

Hôpital Européen Georges Pompidou, Paris Cedex 15, France

Status

Address

Hôpital Européen Georges Pompidou

Paris Cedex 15, , 75908

CHU de Reims, Reims, France

Status

Address

CHU de Reims

Reims, , 51100

Chu Rennes - Hopital Pontchaillou, Rennes, France

Status

Address

Chu Rennes - Hopital Pontchaillou

Rennes, , 35033

CHU Rouen - Hopital Charles Nicolle, Rouen, France

Status

Address

CHU Rouen - Hopital Charles Nicolle

Rouen, , 76031

CHU Saint-Etienne - Hôpital Nord, St Priest en Jarez Cedex, France

Status

Address

CHU Saint-Etienne - Hôpital Nord

St Priest en Jarez Cedex, , 42277

Nouvel Hôpital Civil, Strasbourg, France

Status

Address

Nouvel Hôpital Civil

Strasbourg, , 67091

Hopital Larrey CHU de Toulouse, Toulouse Cedex 9, France

Status

Address

Hopital Larrey CHU de Toulouse

Toulouse Cedex 9, ,

CHU de Nancy - Hôpital de Brabois, Vandoeuvre les Nancy Cedex, France

Status

Address

CHU de Nancy - Hôpital de Brabois

Vandoeuvre les Nancy Cedex, , 54511

Dnipro, Ukraine

Status

Address

CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

Dnipro, , 49059

Lviv Regional Clinical Hospital, Lviv, Ukraine

Status

Address

Lviv Regional Clinical Hospital

Lviv, , 79000

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

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