se of medicines- Hydroxyurea and thalidomide for children suffering from thalassemia
- Conditions
- Health Condition 1: D561- Beta thalassemia
- Registration Number
- CTRI/2023/12/060945
- Lead Sponsor
- ICMR, Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a.Children aged 2-18 years.
b.Diagnosis of transfusion dependent thalassemia, requiring regular blood transfusions.
c.Willing for regular follow up as required for the study
d.Informed consent given
e.Patients with child bearing potential must be willing for contraception (wherever applicable)
a.Patients with hypersplenism and planning splenectomy during the next year
b.Patients planning for hematopoietic stem cell transplantation (HSCT)
c.Retroviral infection
d.Chronic active hepatitis (Hepatitis B or Hepatitis C)
e.Elevation of transaminases more than 5 times of upper limit of normal
f.Renal failure
g.Symptomatic cardiac failure and LVEF < 50%
h.Past history of stroke
i.Received hydroxyurea, thalidomide or luspatercept in the previous 6 months
j.Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method