| CTRI Number |
CTRI/2017/03/008101 [Registered on: 15/03/2017] Trial Registered Prospectively |
| Last Modified On: |
18/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
R-Anti-D immunoglobulin to prevent Rh-D sensitisation of Rh-negative pregnant women |
|
Scientific Title of Study
|
A prospective, randomised clinical trial to confirm safety and efficacy of recombinant anti-D immunoglobulin in prevention of isoimmunisation in comparison with polyclonal anti-D immunoglobulin |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| BSV/r-ANTI D/10 version 3.0 dated 26-April-16 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anahita R Chauhan |
| Address |
Department of Obstetrics & Gynaecology, Seth G. S. Medical College & KEM Hospital,Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
anahitachauhan@gmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
Ganesh Divekar |
| Address |
Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House, Nariman point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
022-45043456 |
| Fax |
022-45043200 |
| Email |
ganesh.divekar@bharatserums.com |
|
Details Contact Person
Public Query
|
| Name |
Ganesh Divekar |
| Address |
Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House, Nariman point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
022-45043456 |
| Fax |
022-45043200 |
| Email |
ganesh.divekar@bharatserums.com |
|
|
Source of Monetary or Material Support
|
| Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House, Nariman point, Mumbai 400 021 |
|
|
Primary Sponsor
|
| Name |
Bharat Serums and Vaccines Ltd |
| Address |
17th floor, Hoechst House, Nariman point, Mumbai 400 021 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Beeram Sumalatha |
Gandhi medical college and Hospital |
"Dept. of OBGY, Secunderabad,
Telangana-500003"
Not Applicable
|
9963528004
sumalatha_08@yahoo.co.in |
| Dr Yamini Trivedi |
AMC MET medical college and Sheth LG general hospital |
1st, obs and gyn department, rambag maninagar ahmedabad
Ahmadabad
|
9825170542
yamilesh2@yahoo.com |
| Dr M D Rashmi |
Apollo BGS Hospital |
Department of Obstetrics & Gynaecology, Apollo BGS Hospital, Kuvempunagar, Mysore-570023
Mysore
|
0821-2568888
drrashmimd@gmail.com |
| Dr Chitra Ramamurthy |
Apollo Hospitals Bangalore |
154/11, consultant, opp IIM bannnergatta road bangalore
Bangalore
|
8026304017
bingiramamurthy@yahoo.co.in |
| Dr Pradip Sambarey |
B J Medical Collge, Pune |
Jai Prakash Narayan Road, Near Pune Railway Station, Pune, Maharashtra 411001
Pune
|
9822294870
drsambarey@yahoo.co.in |
| Dr Kiran Patole |
Dr. Vasantrao Pawar medical college and Research centre |
Depart of obs and gyn, adgaon,
nashik
Nashik
|
9373904679
kpatole@hotmail.com |
| Dr Ashok Anand |
GMC and J J Hospital, Mumbai |
J Marg, Nagpada-Mumbai Central, Off Jijabhoy Road, Mumbai, Maharashtra 400008
Mumbai
|
9702320033
draranand@yahoo.co.in |
| Dr Suchita R Mundle |
Government Medical College, Nagpur |
R-No. 3, Department of Obstetrics and Gynaecology GMC
Medical square road 440003
Nagpur
|
09822706087
srmundle@gmail.com |
| Dr Rekha Sachan |
King George’s Medical University |
Department of Obstetrics & Gynaecology, King George’s Medical University, Chowk, Lucknow - 226 003
Lucknow
|
0522-2761249
drrekhasachan@gmail.com |
| Dr Archana Bhosale |
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospita |
Department of Obstetrics & Gynaecology, L.T.M.M.C. & L.T.M.G.H., Sion, Mumbai - 400022
Mumbai
|
9867168656
aabhosale2006@yahoo.co.in |
| Dr Aruna ramaiah |
Modern government Maternity Hospital |
Supeintendent, prof Obst/Gyn, petlaburz Hyderabad
Hyderabad
|
9490471022
dr.arunaramaiah@gmail.com |
| Dr Vaishali Chavan |
Nobel Hospital Pvt Ltd |
153, Magarpatta City Road, Hadapsar, Pune, Maharashtra 411013
Pune
|
9850058408
drvaishalichavan@gmail.com |
| Dr Trupti Nadkarni |
Nowrosjee Wadia Maternity Hospital |
Department of Obstetrics & Gynaecology, Acharya Donde Marg, Parel, Mumbai- 400012
Mumbai
|
022-24146963
truptidp@rediffmail.com |
| G V Paradkar |
Rajiv Gandhi Medical College And Chhatrapati Shivaji Maharaj hospital |
Department of Obstetrics & Gynaecology Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Kalwa, Thane – 400605
Thane
|
022-25347784
paradkar_g@rediffmail.com |
| Anahita Chauhan |
Seth GS Medical College and KEM Hospital |
Acharya Donde Marg, Parel
Mumbai
|
022-24107466
anahitachauhan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| AMC MET ETHICS COMMITTEE |
Approved |
| Clinical Ethics Committee, Rajiv Gandhi Medical College & Chhatarpati Shivaji Maharaja Hospital |
Approved |
| IECCS of apollo Hospitals Bangalore |
Approved |
| Institutional ethics committee grant government medical college and Sir J J hospital |
Approved |
| Institutional Ethics Committee I, Seth GS Medical College and KEM Hospital |
Submittted/Under Review |
| Institutional ethics committee of BJ govt medical college and sasoon general hospital |
Approved |
| Institutional Ethics Committee, Apollo BSG Hospitals |
Approved |
| Institutional Ethics Committee, Gandhi medical college |
Approved |
| Institutional Ethics Committee, GMC nagpur |
Approved |
| Institutional Ethics Committee, Lokmanya Tilak Municipal Medical College |
Approved |
| Institutional Ethics Committee, Nowrosjee Wadia Maternity Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Vasantrao Pawar Medical college, hospital and Research Center |
Approved |
| Institutional Ethics committee-King Georges Medical University |
Approved |
| Noble hospital Institutional Ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Maternal care for rhesus isoimmunization |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Polyclonal anti-D immunoglobulin |
polyclonal anti-d antibody
300 mcg
postnatally once within 72 hours of delivery
Intramuscular route of administration |
| Intervention |
Recombinant anti-D |
recombinant IgG antibody
300 mcg
postnatally once within 72 hours of delivery
Intramuscular route of administration
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Rh negative pregnant wome delivering Rh positive infants.
2. Patients able to adhere to the study visit schedule .
3. Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Rh D positive or Rh D negative sensitised
2. Rh D negative women delivering Rh D negative infants.
3 Patients who are HIV positive
4. Rh D negative patients with Rh D negative husband. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of RhD sensitisation at the end of the study |
Incidence of RhD sensitisation at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse events
Immunogenicity sample collection negative |
Day 0, post Delivery up to 72 hour, after 72 hour of r-anti-D. Day 30, 90 and 180 |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2017 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
Brief Summary
Modification(s)
|
This was a prospective, multicentre, randomized, open-label, phase II/III clinical study to compare the efficacy and safety of recombinant anti D (Test) with polyclonal anti D (Reference / Rhogam®) in the prevention of Rh iso-immunisation in Rh-negative pregnant women. Single-dose of 300 mcg of either Recombinant Anti D (Test) or Rhogam® (Reference) was administered intramuscularly. A total of 215 enrolled subjects were randomized; 144 subjects to r-Anti D (Test) treatment group and 71 subjects to the Rhogam® (Reference) treatment group. Sensitization (Rh iso-immunisation) as evaluated by positive ICT on Day 180 was not noted in any subject of either of the groups The insignificant p-value for ICT using Fisher’s Exact Test for Day 90 (p=0.30) and Day 180 (p=0.49) proves comparable efficacy between r-Anti D (Test) and Rhogam® (Reference) in the prevention of Rh iso-immunisation in Rh (D) negative pregnant women delivering Rh (D) positive infant. Immunogenicity testing (test to demonstrate the generation of antibodies against Recombinant anti D) demonstrated a negative result; no subject receiving r-Anti D developed antibodies to r-Anti D post administration of the drug |
