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Clinical Trials/CTRI/2022/05/042781
CTRI/2022/05/042781
Recruiting
Phase 3

Study of efficacy of Low dose vs Standard dose of Thalidomide in patients with transfusion dependent thalassemia (TDT): a non-inferiority trial

Pahuja trust for blood disorders0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: D561- Beta thalassemia

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: D561- Beta thalassemia
Sponsor
Pahuja trust for blood disorders
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Pahuja trust for blood disorders

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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