Determination of Correct hydroxyurea dose in Dickle Cell Anemia Patients

Dose evaluation, Population Pharmacokinetic and Pharmacogenetic profiling of Hydroxyurea in Pediatric patients suffering from Sickle Cell Disease in India â?? A randomized controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027022

Enrollment

304

Registered

2020-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D578- Other sickle-cell disorders

Interventions

Intervention1: Hydroxyurea 10 mg/kg/day: Dose: 10 mg/Kg Body weight

Frequency: once a day

Route of administration: Oral

Duration of therapy: One year Control Intervention1: Hydroxyurea 20 mg/kg/day: Dose: 20 mg/Kg Body weight Frequency: once a day Route of administration: Oral Duration of therapy: One year

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Efficacy and Safety of Low dose hydroxyurea might be as equally efficacious as normal dose hydroxyurea. Timepoint: 1. (-2 weeks): Screening for eligibility 2. (0 week): Randomization and drug therapy initiation 3. (2-4 weeks): Follow-up and Pharmacokinetic analysis 4. (12 weeks): Follow-up, efficacy and safety evaluation 5. (24 weeks): Follow-up, efficacy and safety evaluation 6. (36 weeks): Follow-up, efficacy and safety evaluation 7. (48-52 weeks) Final follow-up, efficacy and safety evaluation and Study Closure	—

Measure

Time frame

Efficacy and Safety of Low dose hydroxyurea might be as equally efficacious as normal dose hydroxyurea. Timepoint: 1. (-2 weeks): Screening for eligibility 2. (0 week): Randomization and drug therapy initiation 3. (2-4 weeks): Follow-up and Pharmacokinetic analysis 4. (12 weeks): Follow-up, efficacy and safety evaluation 5. (24 weeks): Follow-up, efficacy and safety evaluation 6. (36 weeks): Follow-up, efficacy and safety evaluation 7. (48-52 weeks) Final follow-up, efficacy and safety evaluation and Study Closure

—

Secondary

Measure	Time frame
Pharmacogenetic analysisTimepoint: Between 2-4 weeks of drug therapy: 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)	—

Countries

India

Contacts

Public ContactDebasish Hota

All India Institute of Medical Sciences, Bhubaneswar

debhota@gmail.com0674-2476011

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026