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New treatment option for Hypertension, Pulmonary
Official title A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
ClinicalTrials.gov ID: NCT05179876
What this study is testing
What is Macitentan?
Macitentan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypertension, pulmonary.
Also referred to as JNJ-67896062.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands...
- Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end...
- A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b)...
You likely can't join if
- General:
- Participants prematurely discontinued from the study intervention in their parent study
- Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study
- Planned or current treatment with another investigational treatment Macitentan-specific:
- Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
- Hemoglobin less than (\<) 80 grams per liter (g/L)
See the full eligibility criteria
- Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing...
- Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study...
- A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the...
- General:
- Participants prematurely discontinued from the study intervention in their parent study
- Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study
- Planned or current treatment with another investigational treatment Macitentan-specific:
- Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
- Hemoglobin less than (\<) 80 grams per liter (g/L)
- Serum aspartate (AST) and/or alanine aminotransferases (ALT) greater than (\>) 3\ upper limit of normal (ULN)
- Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents...
- Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
- Suspected or known pulmonary veno-occlusive disease (PVOD)
- Uncontrolled thyroid disease
- Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure (if not under close medical supervision), severe arrhythmia, cerebrovascular events (for...
- Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents...
- Children only: (a) Current suspicion of intussusception or ileus or gastrointestinal obstruction, per the investigator's judgment; (b) hemoglobin or hematocrit \<75 percent (%) of the lower limit of normal range...
- Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients
- Hemoglobin \<80 g/L
- Serum aspartate (AST) and/or alanine aminotransferases (ALT) \>3\ ULN range
- Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class should be fully assessed and documented in the source documents at screening
- Severe renal impairment (estimated glomerular filtration rate [eGF]/creatinine clearance \<30 milliliter per minute [mL/min])
The study team makes the final eligibility decision.
Where it's taking place
- Minsk, Belarus
- Leuven, Belgium
- Sofia, Bulgaria
- Beijing, China
- Changsha, China
- Nanjing, China
- Qingdao, China
- Shanghai, China
- Xi'an, China
- Budapest, Hungary
- Bialystok, Poland
- Bydgoszcz, Poland
- Katowice, Poland
- Lodz, Poland
- Lublin, Poland
- Szczecin, Poland
- Wroclaw, Poland
- Kemerovo, Russia
- Novosibirsk, Russia
- Saint Petersburg, Russia
+ 16 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minsk, Belarus; Leuven, Belgium; Sofia, Bulgaria; Beijing, China; Changsha, China; Nanjing, China and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.