An exploratory phase II dose escalation study of eltrombopag in MYH9 related disease - ND
- Conditions
- MYH9 related diseaseMedDRA version: 9.1Level: LLTClassification code 10043551Term: Thrombocytopaenia
- Registration Number
- EUCTR2008-001903-42-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Age ≥ 16 years
- Confirmed diagnosis of MYH9RD
- Average platelet count for the previous year less than 50x10 exp9/L
- Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 ≥ 20 mg/L
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method