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CTRI Number  CTRI/2024/08/072981 [Registered on: 27/08/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of thalidomide in a blood disorder requiring repeated blood transfusions 
Scientific Title of Study   Efficacy of thalidomide in transfusion dependent thalassemia: a randomized double blind placebo controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vineeta Gupta 
Designation  Professor 
Affiliation  Department of Pediatrics, Institute of Medical Sciences, BHU 
Address  Room no. 12, Thalassemia Unit Department of Pediatrics Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415336804  
Fax    
Email  vineetaguptabhu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rekhasri Varaprasad 
Designation  Junior resident 
Affiliation  Department of Pediatrics, Institute of Medical Sciences,, BHU 
Address  Room no. 12 Department of Pediatrics Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  7538854746  
Fax    
Email  rekhasrivaraprasad937@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vineeta Gupta 
Designation  Professor 
Affiliation  Department of Pediatrics, Institute of Medical Sciences, BHU 
Address  Room no. 12, Thalassemia Unit Department of Pediatrics Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  09415336804  
Fax    
Email  vineetaguptabhu@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics Institute of Medical Sciences Banaras Hindu University Varanasi-221005, INDIA 
 
Primary Sponsor  
Name  Vineeta Gupta 
Address  Department of Pediatrics Institute of Medical Sciences Banaras Hindu University Varanasi  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineeta Gupta  Institute of Medical Sciences  Room no.12, Thalassemia Unit Department of Pediatrics Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH 		 09415336804

vineetaguptabhu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS, BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D561||Beta thalassemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo  2-3 mg/kg/day for 6 months 
Intervention  Thalidomide  Dose 2-3 mg/kg/day for 6 months 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients of both genders would be selected
Transfusion dependent
Homozygous beta thalassemia
HbE beta thalassemia
Hydroxy urea refractory 
 
ExclusionCriteria 
Details  Pregnant/planning pregnancy/lactating females
Hepatitis B,C and HIV positive patients
Patients with renal, cardiac, liver disease
History of cerebrovascular accidents
Splenectomized patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of blood transfusions required after thalidomide intervention  baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of fall of hemoglobin
Change in RBC indices
Change in serum ferritin, LDH and uric acid levels
Documentation of side effects 		 6 months 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  as indicated

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  as indicated
  3. Who will be able to view these files?
    Response (Others) -  Select researchers

  4. For what types of analyses will this data be available?
    Response (Others) -  as indicated

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vgupta@bhu.ac.in].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 30-06-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This shall be a randomized double blind placebo controlled trial on patients with diagnosis of transfusion dependent thalassemia, 12 to 25 years of both genders registered in the Thalassemia Unit of the Department of Pediatrics, IMS, BHU. Patients would be randomized to receive either thalidomide or placebo. Randomization would be done by computer generated computerized tables. Baseline work up would be done and patients would be entered in the trial after written informed consent. They would be followed up regularly to see their requirement of blood transfusions during 6 months. At the end of 6 months, investigations would be repeated and the requirement of blood transfusions would be calculated to see the effect of thalidomide. 
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