CLINICAL TRIAL FINDER
A Clinical Study in France 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 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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Thomas Pfister, PhD|
|Principal Investigator Affiliation||Actelion|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Enrolling by invitation|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Pulmonary Arterial Hypertension|
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Service de pneumologie et Réanimation Respiratoire, CHU de Bicêtre
Le Kremelin-Bicêtre Cedex, , 94275