Thalidomide for patients with Thalassemia major
Phase 3
- Conditions
- Health Condition 1: D561- Beta thalassemia
- Registration Number
- CTRI/2022/05/042781
- Lead Sponsor
- Pahuja trust for blood disorders
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Any diagnosed patient of TDT who is between age 12-25 years
2. With no current or recent (in past 6 months) of any regular specific drug therapy for hemoglobinopathy
3. Records available to ascertain mean Hb, transfusion frequency and transfusion volumes recieved in preceding 12 weeks period
Exclusion Criteria
1. Weight less than 25 kg or more than 75 kg
2. Known case with HIV, active HCV or Hepatitis B infection
3. Those with any other known systemic illness or known thromboembolic phenomenon
4. Current evidence of hypersplenism
5. Not consenting for contraception if cohabiting
6. Not willing for MTP in case get pregnant while on therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method compare the efficacy of Low dose (1 mg/kg daily) with standard dose (2 mg/kg daily) of <br/ ><br>thalidomide in reducing transfusion requirement in patients with TDTTimepoint: Baseline Hemoglobin, at 12 weeks and at 24 weeks
- Secondary Outcome Measures
Name Time Method Compare ferritin level at 24 weeks and 72 weeks with baseline value in either armsTimepoint: at 24 weeks and 72 weeks;Compare proportion of patients necessitating temporary or permanent cessation of <br/ ><br>drugsTimepoint: at 24 weeks and 72 weeks;Compare proportion of patients with Gr 3/ 4 AEs in both groupsTimepoint: at 24 weeks and 72 weeks;Proportion of patients where iron chelator therapy could be reduced in either arm.Timepoint: at 24 weeks;Proportion of subjects achieving a fair or good response in the two arms at the end <br/ ><br>of 72 weeksTimepoint: end of 72 weeks;Proportion of subjects having no or poor response in the two arms at the end of 72 <br/ ><br>weeks <br/ ><br>Timepoint: end of 72 weeks;Time to response in either group (when the treating centre decides to withhold due <br/ ><br>date transfusion will be considered beginning of response).Timepoint: at 24 weeks