Health Condition 1: D649- Anemia, unspecified
Conditions
Interventions
Intervention1: Low dose hydroxyurea (10 mg/kg): Sickle cell disease patients to receive oral low dose hydroxyurea (10 mg/kg).
Control Intervention1: standard dose Hydroxyurea (20 mg/kg): clinically di
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: a) Sickle cell Anemia patients between 6-18 years of age having weight between 15-60 years either on Hydroxyurea or are started on hydroxyurea and characterized by pain episodes in the past. Painful crisis is defined as a presence of pain for 4 or more hours requiring the intervention with any injectable analgesics. b) 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 immunosuppression drugs. c) Patients with abnormal liver function tests. d) Patients allergic to any drug provided during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)To compare the efficacy of low dose hydroxyurea against the normal dose in pediatric patients suffering from sickle cell disease in terms of pain response.Timepoint: 2, 4 and 6 months after baseline monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) To compare the efficacy of low and normal dose hydroxyurea in patients with sickle cell disease in terms of change in HbF levels. b) To determine the population pharmacokinetic profile of hydroxyurea in Indian patients. c) To demonstrate the superiority of low dose hydroxyurea against a normal dose preparation in terms of safety Timepoint: 2, 4 and 6 months after baseline monitoring. | — |
Countries
India
Contacts
Public ContactDebasish Hota
AIIMS Bhubaneswar
Outcome results
None listed