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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01133860
Eligibility Criteria:
Inclusion Criteria:
* Age 16 years or more
* Confirmed diagnosis of MYH9-related disease
* Average platelet count for the previous year less than 50x10e9/L
* Written informed consent
Exclusion Criteria:
* Diseases known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
* History of thrombosis within 1 year
* Use of drugs that affect platelet function (including but not limited to, aspirin, clopidogrel or NSAIDS) or anti-coagulants
* Females who are pregnant or nursing (a negative pregnancy test in required before enrollment of fertile women)
* Formal refusal of any recommendation of a safe contraception
* Alcohol or drug addiction
* Altered renal function as defined by creatinine of 20 mg/L or more
* Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioral problems. HCV positivity and liver diseases will not be considered an exclusion criterion since a phase II study showed that eltrombopag was effective and safe in this patient population.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01133860
Study Brief:
Protocol Section:
NCT01133860