Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04629651
Eligibility Criteria:
Inclusion Criteria:
* Participants must have histologically confirmed diagnosis of primary myelofibrosis (PMF), or post-polycythemia vera/essential thrombocythemia-MF (i.e. secondary MF) by 2016 WHO criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 -2
* Creatinine clearance \>30 ml/minute
* Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment. All men and women of childbearing potential must use acceptable methods of birth control throughout the study.
* Participants should be able to give voluntary informed written consent to participate in the study. Informed consent will be obtained prior to enrollment and before any study-related procedure is done that is not part of standard medical care, with the understanding that consent may be withdrawn by the participants any time without prejudice to future medical care.
Exclusion Criteria:
* Completed hematopoietic cell transplant (HCT)
* Presence of \>10% blasts in peripheral blood or on bone marrow examination
* Screening blood pressure(BP)parameters of systolic BP \< 100 and diastolic BP \< 60
* Splenic irradiation within 3 months prior to the first dose of captopril
* Prior ACE inhibitor, angiotensin II receptor antagonist, or aliskiren use within 12 months prior to trial enrolment
* Known allergy/hypersensitivity to ACE inhibitors
* Participants receiving any other investigational agents
* Pregnant or nursing participants - captopril is a risk category D and is excreted in breast milk
* Participants with creatinine clearance \<30 ml/minute or on dialysis
* Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04629651
Study Brief:
Protocol Section:
NCT04629651