Clinical trial of Methotrexate associated to Hydroxyurea versus placebo and Hydroxyurea in patients with sickle cell disease
Phase 2
- Conditions
- Sickle-cell anaemia with crisisanemia, sickle cellpaininflammationD57.0C15.378.071.141.150.150C23.888.592.612C23.550.470
- Registration Number
- RBR-57qbjv
- Lead Sponsor
- Centro Infantil Boldrini
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Sickle Cell Disease patients; aged 08-30 years; patients who have vaso-occlusive pain episodes despite the regular use of hydroxyurea in the clinically-adjusted dose for a period equal or superior to 24 weeks
Exclusion Criteria
Absence of a signed Subject Information and Consent Form/Parents’ or legal guardian’s Informed Permission; renal or hepatic insufficiency; infection at enrollment time; pregnancy or breastfeeding; regular and/or frequent blood transfusions; refusal of contraceptive measures by females in reproductive age
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method