| CTRI Number |
CTRI/2025/08/093411 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate efficacy and safety of Human normal immunoglobulin given in veins in patients with Immune thrombocytopenia (Low levels of the cells that help blood clot) |
|
Scientific Title of Study
|
An Open- Label, Multicenter, Phase III Clinical Study in India to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous use (IVIG) in Chronic Immune Thrombocytopenia (ITP) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSV_IVIG_ITP_2023_02 Version 4.0 dated 17.04.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Jagannathan |
| Designation |
Vice President Clinical research and pharmacovigilance |
| Affiliation |
Bharat serums and Vaccines LTd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
| Phone |
02245043456 |
| Fax |
|
| Email |
Ramesh.jagannathan@bsvgroup.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan Manguesh |
| Designation |
DGM Medical Affairs |
| Affiliation |
Bharat serums and Vaccines LTd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
| Phone |
02245043456 |
| Fax |
|
| Email |
Rajan.manguesh@bsvgroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan Manguesh |
| Designation |
DGM Medical Affairs |
| Affiliation |
Bharat serums and Vaccines LTd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
| Phone |
02245043456 |
| Fax |
|
| Email |
Rajan.manguesh@bsvgroup.com |
|
|
Source of Monetary or Material Support
|
| Bharat Serums and Vaccines Ltd.
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
|
|
Primary Sponsor
|
| Name |
Bharat Serums and Vaccines Ltd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeraj Sidharthan |
Amrita Institute of Medial Sciences |
AIMS Ponekkara P O
Kochi - 682041,
Ernakulam
KERALA |
9946047464
neerajsidh@gmail.com |
| Dr Biju George |
Christian Medical College (CMC) Vellore Ranipet Campus |
A501, A Block, Fifth Floor, Department of haematology CMC Vellore- Ranipet campus,Kilminnal Village, PO Ranipet District 632517
Vellore
TAMIL NADU |
8056416705
biju@cmcvellore.ac.in |
| Dr Vijay Ramanan Madatha |
Grant Medical Foundation Ruby Hall Clinic |
Cancer Building, 1st Floor
Grant Medical Foundation Ruby Hall Clinic
Pune
MAHARASHTRA |
9822240022
mvijayr@gmail.com |
| Dr Sunita Agarwal |
Maulana Azad Medical College |
Room Number- 122, 5th floor; Haematology Department, Department of Medicine,
B L Taneja Block,
Maulana Azad Medical College, Bahadur Shah, Zafar Marg
110002
New Delhi
DELHI |
9968604281
drsunita.mamc@gmail.com |
| Dr Sharat Damodar |
Mazumdarshaw Medical Center, Narayana Hrudayalaya Ltd |
Department of Haematooncology, 7th Floor, A Block, 258/A, Bommasandra Industrial Area, Hosur Road, Anekkal Taluk.
Bangalore
KARNATAKA |
9880437134
drsharat.damodar@gmail.com |
| Dr Prakas Kumar Mondal |
Nil Ratan Sircar Medical college and Hospital |
Room number-6; 5th floor; Haematology Department
138, Acharya Jagdish Chandra Bose Rd, Kolkata
Kolkata
WEST BENGAL |
9433345001
prakas70@gmail.com |
| Dr Pankaj Malhotra |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh |
Department of Clinical Hematology and Medical Oncology, 4th floor, F block Nehru Hospital, Postgraduate Institute of Medical Education and research, Sector 12 -160012
Chandigarh
CHANDIGARH |
7087009680
malhotrapankaj@hotmail.com |
| Dr Shashikant Janardhan Apte |
Sahyadri Super Speciality Hospital Deccan |
Department of Heamatology and Bone Marrow Transplant, Ground Floor, OPD no.-05 Plot no. 30C, Erandawane, Karve Road, 411004
Pune
MAHARASHTRA |
9175980913
shashikant.apte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Commitee, NRS Medical College and Hospital |
Approved |
| Ethics Committee, Institutional Review Board, CMC Vellore |
Submittted/Under Review |
| Institutional Ethics Committee Amrita Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee MAMC |
Submittted/Under Review |
| Institutional Ethics Committee Poona Medical Research Foundation |
Submittted/Under Review |
| Narayana Health Medical Ethics Committee |
Submittted/Under Review |
| Postgraduate Institute of Medical Education and research |
Submittted/Under Review |
| Sahyadri Hospitals Private Limited Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D693||Immune thrombocytopenic purpura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Human Normal Immunoglobulin (IVIG) for Intravenous use |
IVIG is 0.8 - 1 g/kg on day one, which may be repeated once within 3 days (72 hours) of the first dose or 0.4 g/kg daily for two to five days |
| Comparator Agent |
Not a comparative study |
not a comparative study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of Chronic ITP of atleast 12 months duration
Platelet count more than 30,000 per mm3 at screening.
absence of other conditions that could cause thrombocytopenia.
If subjects are currently being treated with corticosteroids the treatment regimen or dose must have been stable.
if subjects are currently being created with cyclophosphamide, azathioprine or attenuated androgens the treatment regimen and dose must have been stable.
Splenectomized subjects and both RhD positive and Rh-D negative subject can be included.
if subect is a female of child-bearing potential, she must have a negative result on urine-based human chorionic gonadotropin pregnancy test.
if subject is a female who is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
Subect has history of any severe or anaphylactic reaction to IVIG or any other IgG preparation or its excipients.
Subject has received an IVIG preparation within 1 month prior to screening.
Received any blood, blood product, or blood derivative within the 1 month before screening.
Received Rituximab within the 3 months before screening.
Subject is pregnant or is in a period of lactation
Subject has a severe renal impairment
Subject is known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs with abuse potential in the past 12 months.
Subject has a history of deep vein thrombosis (DVT) or thrombotic complications of IVIG therapy
subject has any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina
Subject suffers from any acute or chronic medical conditions that may interfere with the conduct of study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The number and percentage of subjects with response (R). |
up to day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The number and percentage of subjects with CR, LR, and NR |
up to day 28 |
| Time (in days) from treatment to R |
up to day 28 |
| Time (in days) from treatment to CR |
up to day 28 |
| Duration (in days) of R |
up to day 28 |
| Duration (in days) of CR |
up to day 28 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/09/2025 |
| 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="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open-label, multicenter, Phase III clinical study to evaluate the efficacy and safety of IVIG in Indian adult Subjects with immune thrombocytopenia (ITP). Eligible adult subjects with chronic ITP will be enrolled in the study. Subjects will receive IVIG, and the efficacy and safety parameters will be assessed at specified intervals up to day 28. All the outcome measures will be assessed until the end of the study visit (day 28). |