Determination of Correct hydroxyurea dose in Dickle Cell Anemia Patients
- Conditions
- Health Condition 1: D578- Other sickle-cell disorders
- Registration Number
- CTRI/2020/08/027022
- Lead Sponsor
- ICMR New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a) Newly diagnosed patients of less than 18 years of age with sickle cell disease as characterized by three or more painful crisis over the period of 12 months and the requirement of 2 or more blood transfusions over the same period. Painful crisis is defined as a presence of pain for 4 or more hours requiring the intervention with any injectable analgesics.
b) Patients should be homozygous for sickle cell disease (HbSS).
c) Patients willing to provide informed consent and assent.
a) Patients with other forms of sickle cell syndromes.
b) Patients on any immunosuppressant drugs.
c) Patients with abnormal liver function tests.
d) Patients allergic to any drug provided during the study period.
e) Patients on drugs interfering with the metabolism of hydroxyurea.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and Safety of Low dose hydroxyurea might be as equally efficacious as normal dose hydroxyurea. <br/ ><br>Timepoint: 1. (-2 weeks): Screening for eligibility <br/ ><br>2. (0 week): Randomization and drug therapy initiation <br/ ><br>3. (2-4 weeks): Follow-up and Pharmacokinetic analysis <br/ ><br>4. (12 weeks): Follow-up, efficacy and safety evaluation <br/ ><br>5. (24 weeks): Follow-up, efficacy and safety evaluation <br/ ><br>6. (36 weeks): Follow-up, efficacy and safety evaluation <br/ ><br>7. (48-52 weeks) Final follow-up, efficacy and safety evaluation and Study Closure
- Secondary Outcome Measures
Name Time Method Pharmacogenetic analysisTimepoint: Between 2-4 weeks of drug therapy: <br/ ><br>The cellular component of the blood samples collected during pharmacokinetic analysis will be utilized for pharmacogenetic analysis;Pharmacokinetic parametersTimepoint: Between 2-4 weeks of drug therapy (one time)