| CTRI Number |
CTRI/2025/11/097416 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate effect of human normal immunoglobulin in adult and children whose immune sytem is not working properly |
|
Scientific Title of Study
|
An open-label, single-arm, prospective, multicenter, phase 3 study to evaluate the efficacy, safety and pharmacokinetics of human normal immunoglobulin for intravenous use in adult and paediatric subjects with primary immunodeficiency syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSV_IVIG_PID_2023_03 V2.0 dated 10-Oct-2024 |
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
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suma Balan |
Amrita Institute of Medical Sciences |
AIMS Ponekkara P O, Kochi - 682041
Ernakulam
KERALA |
9745106719
sumab@aims.amrita.edu |
| Dr Rohit H R |
BGS Global Institute of Medical Sciences |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060
Bangalore
KARNATAKA |
8792516793
drrohith.research@gmail.com |
| Dr Biju George |
Christian Medical College Vellore |
06th floor, A Block, Department of Haematology,
Christian Medical College Vellore, Ranipet Campus,
Kilminnal Village, 632517, Ranipet District
Vellore
TAMIL NADU |
8056416705
biju@cmcvellore.ac.in |
| Dr Richa Giri |
GSVM Medical college |
Kailash pat singhania Post Graduate Department of medicine, LLR Hospital, GSVM Medical college, Swaroop Nagar, Kanpur, 208002
Kanpur Nagar
UTTAR PRADESH |
8400331045
richa.277@rediffmail.com |
| Dr Priyankar Pal |
Institute of Child Health |
Consultant room no. 11, Dr. Biresh Guha Street, Kolkata-700017
Kolkata
WEST BENGAL |
9831061736
mailme.priyankar@gmail.com |
| Dr Liza Rajasekhar |
Nizams Institute of Medical Sciences |
Department of Clinical Immunology and Rheumatology, Nizams Institute of Medical Sciences, Millennium Block, 4
Punjagutta 500082
Hyderabad
TELANGANA |
9391008618
lizarajasekhar@gmail.com |
| Dr Shweta Bansal |
Paediatric Haematology and Oncology Department |
Sir H. N. Reliance Foundation Hospital and Research Centre
Raja Rammohan Roy Road, Prathana Samaj,Girgaon, 400004
Mumbai
MAHARASHTRA |
9920266062
shweta.bansal@rfhospital.org |
| Dr Nita Radhakrishnan |
Post Graduate Institute of Child Health |
4th Floor, Department od pediatrics, Post Graduate Institute Of Child Health
Sector 30
Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9999041524
nitark@gmail.com |
| Dr Rudrarpan Chatterjee |
Sanjay Gandhi PGI of Medical Sciences |
Department of Clinical Immunology and Rheumatology, New PMSSY Rd, Raibareli Road, -226014
Lucknow
UTTAR PRADESH |
8108403686
rudi.gmc2009@gmail.com |
| Dr Avinash Jain |
SMS Hospital |
Department of Clinical Immunology and Rheumatology, Room No. 135, 1st Floor, Dhanwantari OPD Blocks
LN Marg, 302004
Jaipur
RAJASTHAN |
9602045584
docavinashjain@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospitals |
Approved |
| GSVM MEDICAL COLLEGE ethics Committee |
Approved |
| Institutional Ethics Committee of Sir H. N. Reliance Foundation Hospital and Research Centre |
Approved |
| Institutional Ethics committee, Amrita IIMS |
Approved |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, ICH Institute of Child Health |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Child Health |
Approved |
| Institutional Ethics Committee, Sanjay Gandhi PGI of Medical Sciences |
Approved |
| Institutional Reveiw Board CMC Vellore |
Approved |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D849||Immunodeficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Human Normal Immunoglobulin (IVIG) for Intravenous use |
Recommended starting dose of 400-800 mg per kg per infusion, followed by 200-800
mg per kg per infusion every 21 or 28 days, intravenously for a period of 12 months. |
| Comparator Agent |
Not a commparative study |
Not a commparative study |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with a confirmed clinical diagnosis of a PID
2. Has received 200-800 mg/kg of licensed IVIG therapy at 21 or 28 days intervals for 3 months
3. 2 documented IgG trough levels of more than equal to 5 g per L are obtained at 2 infusion cycles
4. Subject is willing to comply with all requirements of the protocol
5. Females of child-bearing potential with a negative urine pregnancy test
|
|
| ExclusionCriteria |
| Details |
1. Has secondary immunodeficiency
2. Newly diagnosed and has not been treated with immunoglobulin history of repeated reactions or hypersensitivity to IVIG
3. Has received blood products
4. Has an acute infection
5. Has profound anemia
6. Severe chronic condition such as renal failure, etc
7. Has a history of a malignant disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| measures the incidence of acute serious bacterial infections |
End of study 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Unable to perform normal daily activities |
End of study 12 months |
| Unscheduled physician/clinic visits |
End of study 12 months |
| Hospitalizations/admission in hospital due to infection |
End of study 12 months |
| Use of Therapeutic antibiotics and duration of their use |
End of study 12 months |
| Incidence of new infections other than acute serious bacterial infections |
End of study 12 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
25/11/2025 |
| 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="2"
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 a phase 3 open-label, single-arm, prospective, multicenter in adults and paediatric subjects with PID and on IVIG treatment (at least 3 infusion). Approximately, 42 subjects will be evaluated in the study. All subjects will receive IV infusions of the IVIG at the same dose and interval as was administered before enrolment into the study. |