Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (MERIT-2)

• ClinicalTrials.gov Identifier: NCT02060721
• Recruitment Status: Active, not recruiting
• First Posted: February 12, 2014
• Last Update Posted: February 17, 2021
• Sponsor: Actelion
• Information provided by (Responsible Party): Actelion

Study Description

Brief Summary:

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Condition or disease	Intervention/treatment	Phase
Chronic Thromboembolic Pulmonary Hypertension	Drug: Macitentan	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 76 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
• Actual Study Start Date: February 3, 2015
• Estimated Primary Completion Date: December 22, 2021
• Estimated Study Completion Date: December 22, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Macitentan; Macitentan 10mg, oral tablet, once daily	Drug: Macitentan; Macitentan 10mg, oral tablet, once daily; Other Name: ACT-064992

Outcome Measures

Primary Outcome Measures :

1. Treatment-emergent adverse events (AEs) up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
2. AEs leading to premature discontinuation of study drug. [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
3. Treatment-emergent serious adverse events up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
4. Treatment-emergent marked laboratory abnormalities up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
5. Change in vital signs (arterial blood pressure, heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 24 months ]

Other Outcome Measures:

1. Change from baseline to each scheduled time point inexercise capacity, as measured by the 6MWD [ Time Frame: Baseline up to 30 months ]
2. Change from baseline to each scheduled time point in Borg dyspnea index [ Time Frame: Baseline up to 30 months ]
3. Proportion of subjects with worsening of WHO FC from baseline to each scheduled time point. [ Time Frame: Baseline up to 30 months ]
4. marked laboratory abnormalities during treatment period and up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]
5. Change in vital signs (blood pressure , heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Written informed consent
• Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
• Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.

Exclusion Criteria:

• Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
• Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.

Contacts and Locations

Locations

Belgium

Leuven, Belgium

China

Beijing, China

Guangzhou, China

Shanghai, China

Shenyang, China

Wuhan, China

Czechia

Praha 2, Czechia

France

Le Kremlin-Bicetre Cedex, France

Paris Cedex 15, France

Toulouse Cedex 9, France

Germany

Giessen, Germany

Heidelberg, Germany

Würzburg, Germany

Hungary

Budapest, Hungary

Debrecen, Hungary

Lithuania

Kaunas, Lithuania

Mexico

Ciudad de Mexico, Mexico

Poland

Lublin, Poland

Wrocław, Poland

Russian Federation

Kemerovo, Russian Federation

Moscow, Russian Federation

Novosibirsk, Russian Federation

St Petersburg, Russian Federation

Tomsk, Russian Federation

Switzerland

Zürich, Switzerland

Thailand

Bangkok, Thailand

Chiang Mai, Thailand

Turkey

Capa_Istanbul, Turkey

Ukraine

Kyiv, Ukraine

Lviv, Ukraine

United Kingdom

Cambridge, United Kingdom

London, United Kingdom

Sheffield, United Kingdom

Sponsors and Collaborators

Actelion

Investigators

• Study Director: Erin McGuire; Actelion

More Information

• Responsible Party: Actelion
• ClinicalTrials.gov Identifier: NCT02060721
• Other Study ID Numbers: AC-055E202; 2013-003457-25 ( EudraCT Number )
• First Posted: February 12, 2014
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

Keywords provided by Actelion:

Chronic thromboembolic pulmonary hypertension (CTEPH)

Additional relevant MeSH terms:

Macitentan; Hypertension, Pulmonary; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Endothelin A Receptor Antagonists; Endothelin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Endothelin B Receptor Antagonists