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.

NCT03422328 | Completed Phase 3

• 2 other identifiers: AC-055-3142017-003934-10
• Study Type: interventional
• Target: 151
• Locations: 6 countries
• Sites: 33

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.

Conditions

Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Keywords

macitentan; long-term safety; open-label; single-arm

Outcome Measures

Primary Outcomes (4)

• Incident Rate of Treatment-emergent Adverse Event

  An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A treatment-emergent AE is any AE temporally associated with the use of study treatment.

  From Day 1 to End of study (EoS) visit (an average of 3 years)

• Incident rate of treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment

  Any AE will be recorded that 1) is (temporally) associated with the use of study treatment whether or not considered by the investigator as related to study treatment and 2) leads to premature discontinuation of study medication.

  From Day 1 to EoS visit (an average of 3 years)

• Incident rate of treatment-emergent serious adverse events (SAEs)

  Any SAE as defined by the ICH guidelines will be recorded. Any hepatic AE that leads to discontinuation of study treatment will be defined as SAE.

  From Day 1 to EoS visit (an average of 3 years)

• Number of pregnancies with maternal exposure to macitentan

  Pregnancies with maternal exposure to macitentan will be recorded.

  From Day 1 to EoS visit (an average of 3 years)

Other Outcomes (2)

• Change of WHO functional class to each scheduled time point

  From Day 1 to EoT visit (an average of 3 years)

• Assessment of survival status at End-of-Study (EoS)

  From Day 1 to EoS visit (an average of 3 years)

Study Arms (1)

Open-label macitentan 10 mg

EXPERIMENTAL

10 mg macitentan film coated tablet, administered orally once daily

Drug: macitentan

Interventions

macitentan DRUG

macitentan 10 mg, film-coated tablet, oral use

Also known as: ACT-064992, JNJ-67896062

Open-label macitentan 10 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to take part in the study before any study mandated procedure.
• 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
• 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

You may not qualify if:

• Hemoglobin less than 80 gram per liter (g/L)
• Serum Aspartate aminotransferase (AST) and/or alanine aminotransferases (ALT) more than three times the upper limit of normal range
• Known and documented history of severe hepatic impairment that is Child-Pugh Class C.
• Pregnant, planning to become pregnant, or breastfeeding
• Known hypersensitivity to macitentan, its excipients, or drugs of the same class
• Planned or current treatment with another investigational treatment up to 3 months prior to Enrollment
• 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
• Treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)

Sponsors & Collaborators

• Actelion: lead

Study Sites (34)

The Republican Scientific-Practical Center ''Cardiology''

Minsk, 220036, Belarus

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHRU Besancon Hopital Jean Minjoz

Besançon, 25030, France

Location

CHU de Bordeaux - Hospital Haut-Leveque

Bordeaux (Pessac), 33604, France

Location

CHU de la Cavale Blanche

Brest, 29609, France

Location

GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

Bron, 69677, France

Location

Hôpital Côte de Nacre

Caen, France

Location

CHU Dijon

Dijon, 21079, France

Location

CHU Grenoble

Grenoble, 38700, France

Location

Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Cardiologique - Chru Lille

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87042, France

Location

CHU de la Timone

Marseille, 13005, France

Location

CHU de Montpellier - Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU Nantes - Hopital Nord Laënnec

Nantes, 44093, France

Location

Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

Nice, 06001, France

Location

Hopital Europeen Georges Pompidou

Paris, 75908, France

Location

CHU de Reims

Reims, 51100, France

Location

Chu Rennes Hopital Pontchaillou

Rennes, 35033, France

Location

CHU Rouen Hopital Charles Nicolle

Rouen, 76031, France

Location

CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, 42277, France

Location

Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Hopital Larrey CHU de Toulouse

Toulouse, France

Location

CHU de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

Lublin, 20 718, Poland

Location

Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny

Wroclaw, 51 124, Poland

Location

Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

Kemerovo, 650002, Russia

Location

National Medical Research Center of Cardiology of MoH of Russian Federation

Moscow, 121552, Russia

Location

Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation

Novosibirsk, 630055, Russia

Location

Federal North-West Medical Research Centre

Saint Petersburg, 197341, Russia

Location

Federal State Budget Scientific Institution

Tomsk, 634012, Russia

Location

Istanbul University Istanbul Medical Faculty

Capa_Istanbul, 34093, Turkey (Türkiye)

Location

CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

Dnipro, 49059, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79000, Ukraine

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

macitentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marek Sochor

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is designed as an open-label, single-arm, multicenter trial in which all participants roll over from a "parent study" in order to continue their dose of macitentan 10 mg once every day as already received in the "parent study".

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: April 5, 2018
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

UA (2); FR (22); BE (1); PL (2); RU (5); TU (1)