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.

NCT ID: NCT03422328

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2023-12-27

Brief Summary

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.

Detailed Description

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.

Conditions

Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label macitentan 10 mg

10 mg macitentan film coated tablet, administered orally once daily

Group Type: EXPERIMENTAL

macitentan

Intervention Type: DRUG

macitentan 10 mg, film-coated tablet, oral use

Interventions

macitentan

macitentan 10 mg, film-coated tablet, oral use

Intervention Type: DRUG

Other Intervention Names

ACT-064992; JNJ-67896062

Eligibility 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 may 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marek Sochor

Role: STUDY_DIRECTOR

Actelion

Locations

The Republican Scientific-Practical Center ''Cardiology''

Minsk, , Belarus

UZ Leuven

Leuven, , Belgium

CHRU Besancon Hopital Jean Minjoz

Besançon, , France

CHU de Bordeaux - Hospital Haut-Leveque

Bordeaux (Pessac), , France

CHU de la Cavale Blanche

Brest, , France

GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

Bron, , France

Hôpital Côte de Nacre

Caen, , France

CHU Dijon

Dijon, , France

CHU Grenoble

Grenoble, , France

Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud

Le Kremlin-Bicêtre, , France

Hôpital Cardiologique - Chru Lille

Lille, , France

CHU de Limoges

Limoges, , France

CHU de la Timone

Marseille, , France

CHU de Montpellier - Arnaud de Villeneuve

Montpellier, , France

CHU Nantes - Hopital Nord Laënnec

Nantes, , France

Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

Nice, , France

Hopital Europeen Georges Pompidou

Paris, , France

CHU de Reims

Reims, , France

Chu Rennes Hopital Pontchaillou

Rennes, , France

CHU Rouen Hopital Charles Nicolle

Rouen, , France

CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, , France

Nouvel Hopital Civil

Strasbourg, , France

Hopital Larrey CHU de Toulouse

Toulouse, , France

CHU de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, , France

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

Lublin, , Poland

Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny

Wroclaw, , Poland

Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

Kemerovo, , Russia

National Medical Research Center of Cardiology of MoH of Russian Federation

Moscow, , Russia

Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation

Novosibirsk, , Russia

Federal North-West Medical Research Centre

Saint Petersburg, , Russia

Federal State Budget Scientific Institution

Tomsk, , Russia

Istanbul University Istanbul Medical Faculty

Capa_Istanbul, , Turkey (Türkiye)

CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

Dnipro, , Ukraine

Lviv Regional Clinical Hospital

Lviv, , Ukraine

Countries

Belarus; Belgium; France; Poland; Russia; Turkey (Türkiye); Ukraine

Other Identifiers

2017-003934-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-055-314

Identifier Type: -

Identifier Source: org_study_id