| CTRI Number |
CTRI/2022/12/048540 [Registered on: 27/12/2022] Trial Registered Prospectively |
| Last Modified On: |
24/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Hydroxyurea and Thalidomide in Thalassemia patients |
|
Scientific Title of Study
|
Phase-3, Multicentric, open label trial to evaluate the efficacy of Hydroxyurea and Thalidomide in Thalassemia patients |
| Trial Acronym |
HATT Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1286-1892 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Y |
| Designation |
Professor (Medicine) and Hematologist |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Internal Medicine, Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| Fax |
|
| Email |
udayj2yanamandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Y |
| Designation |
Professor (Medicine) and Hematologist |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Internal Medicine, Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| Fax |
|
| Email |
udayj2yanamandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nirmal Shrestha |
| Designation |
PG Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Internal Medicine, Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| Fax |
|
| Email |
nirmal.afmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| O/O Director General Armed Forces Medical Services, Integrated Headquarters of Defence, Ministry of Defence, 108E, Church Rd, North Block, Rakab Ganj, New Delhi, Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
DGAFMS |
| Address |
IHQ (ARMY), MINISTRY OF DEFENCE |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uday Y |
Command Hospital (Southern Command) |
Dept of Hematology, block 7, 3rd Floor, Medical Division, Command Hospital (Southern Command), Pune
Pune
MAHARASHTRA |
8195035551
udayj2yanamandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D561||Beta thalassemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydroxyurea |
Upto 15mg per kg per day orally for 6 months |
| Intervention |
Hydroxyurea and Thalidomide |
Hydroxyurea upto 15mg per kg per day orally and Thalidomide upto 3 mg per kg per day orally along with Aspirin 5mg per kg per day orally for 06 months |
| Comparator Agent |
Standard of care |
Standard of care |
| Intervention |
Thalidomide |
Upto 3mg per kg per day orally along with Aspirin 5mg per kg per day orally for 06 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of transfusion-dependent thalassemia
2. ECOG: 0 to 2 scores
3. Blood transfusion to maintain the Hb or level of Hb<9g/dl if not transfused
4. Sign an informed consent agreeing to the clinical trial participation
|
|
| ExclusionCriteria |
| Details |
1. Patients with comorbidities like severe heart or lung diseases, liver dysfunction, renal dysfunction, malignancy, cerebrovascular disease, or other serious primary diseases
2. Patients allergic to the drug ingredients
3. Patients with any mental health problem
4. Patients had participated in other drug clinical trials in the past 1 month
5. Patients had a history of venous or arterial thrombosis
6. Childbearing age unwilling to use contraceptive measures
7. In certain circumstances the researchers determined it was not suitable for the research
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Blood transfusion pre and post intervention in ml/kg/month |
at 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Serum Ferritin pre and post intervention
2. Nadir Hemoglobin pre and post intervention |
at 06 months
|
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
30/12/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to explore the effectiveness of hydroxyurea and thalidomide in the treatment of transfusion dependent thalassemia (TDT) to improve the haemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion. The project is a multi-arm, multicentric research of hydroxyurea and thalidomide in transfusion-dependent thalassemia patients. Patients volunteering to participate in this trial and meeting the inclusion criteria will be enrolled. Participants will be randomised to either hydroxyurea or thalidomide or both hydroxyurea and thalidomide or standard of care arm. 40 patients will be allocated to each group and the estimated duration of study is 03 years. Dosage of hydroxyurea will be up to 15 mg/kg and thalidomide up to 3 mg/kg along with aspirin 5mg per kg per day. During this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions will be closely observed and blood transfusion will be done if hemoglobin levels is below 8 g/dl.
|