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Trial record 1 of 1 for:    NCT03422328
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A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Arterial Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03422328
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2018
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

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) who were previously treated with macitentan in clinical studies.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: macitentan Phase 3

Detailed Description:
The purpose of this study is to provide continued treatment with macitentan to subjects with PAH who participated or participate in "parent studies" in France and to continue to accrue long-term safety data. "Parent study/studies" refer to a number of clinical studies with macitentan that are conducted in different clinical classification of PAH (NCT00667823, NCT02112487, NCT02310672, NCT02968901, NCT02558231) and may be completed before the participating subjects have access to commercial macitentan in their country of residence. The "parent studies" are fully or partially running in France where no access to commercial macitentan is expected in the near future.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The study is designed as an open-label, single-arm, multicenter trial in which all subjects 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 studies".
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 (UMBRELLA)
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : April 3, 2021
Estimated Study Completion Date : May 2, 2021


Arm Intervention/treatment
Experimental: Open-label macitentan 10 mg
10 mg macitentan film coated tablet, administered orally once daily
Drug: macitentan
macitentan 10 mg, film-coated tablet, oral use




Primary Outcome Measures :
  1. Incident rate of treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment [ Time Frame: From Day 1 to End-of-Study (EoS) visit (36 months + 30 days follow-up) ]
    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.

  2. Incident rate of treatment-emergent serious adverse events (SAEs) [ Time Frame: From Day 1 to EoS visit (36 months + 30 days follow-up) ]
    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.

  3. Number of pregnancies with maternal exposure to macitentan [ Time Frame: From Day 1 to End-of-Treatment (EoT) visit (36 months) ]
    Pregnancies with maternal exposure to macitentan will be recorded.


Other Outcome Measures:
  1. Change of WHO functional class to each scheduled time point [ Time Frame: From Day 1 to EoT visit (36 months) ]
    The proportion of patients who worsened, remain unchanged or improved from baseline to each scheduled time-point in WHO function will be collected, where baseline is the initial baseline from the "parent study" (or the double-blind core study preceding the "parent study").

  2. Assessment of survival status at End-of-Study (EoS) [ Time Frame: From Day 1 to EoS visit (36 months + 30 days follow-up) ]
    Time to death of all causes up to EoS from the date of randomization or enrollment in the "parent study" (or the double-blind core study preceding the "parent study") will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent to take part in the study before any study mandated procedure.
  2. Subjects currently treated with macitentan in a clinical study that is about to come to an end in France.
  3. Women of childbearing potential are able to take part in the study if the following applies:

    1. Urine pregnancy test is negative at Enrollment.
    2. Agreement to perform monthly urine or serum pregnancy tests during the study and up to at least 30 days after the study treatment discontinuation.
    3. 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 g/L.
  2. Serum aspartate (AST) and/or alanine (ALT) aminotransferases more than three times the upper limit of normal range.
  3. Known and documented history of severe drug-induced hepatic impairment (with or without cirrhosis).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422328


Locations
Show Show 27 study locations
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Thomas Pfister, PhD Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03422328    
Other Study ID Numbers: AC-055-314
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Actelion:
macitentan
long-term safety
open-label
single-arm
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists