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.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03422328
• Date of registration: 30/01/2018
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: 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. UMBRELLA
• Scientific title: mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies
• Date of first enrolment: April 5, 2018
• Target sample size: 147
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03422328
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belarus, Belgium, France, Poland, Russian Federation, Turkey, Ukraine

Contacts

• Name: Marek Sochor
• Affiliation: Actelion

Key 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 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)



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Thromboembolic Pulmonary Hypertension

Pulmonary Arterial Hypertension

Intervention(s)

Drug: macitentan

Primary Outcome(s)

Incident Rate of Treatment-emergent Adverse Event [Time Frame: From Day 1 to End of study (EoS) visit (an average of 3 years)]

Number of pregnancies with maternal exposure to macitentan [Time Frame: From Day 1 to EoS visit (an average of 3 years)]

Incident rate of treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment [Time Frame: From Day 1 to EoS visit (an average of 3 years)]

Incident rate of treatment-emergent serious adverse events (SAEs) [Time Frame: From Day 1 to EoS visit (an average of 3 years)]

Secondary ID(s)

AC-055-314

2017-003934-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors