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CTRI Number  CTRI/2015/09/006172 [Registered on: 09/09/2015] Trial Registered Prospectively
Last Modified On: 10/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   study of drug (rhoclone) on Rh negative blood group mother giving birth to Rh positive blood group baby 
Scientific Title of Study   A Prospective, Randomized, Open Label, Phase III, Multicentric Clinical Trial To Compare The Efficacy And Safety Of Monoclonal Anti Rho (D) Immunoglobulin With Polyclonal Anti Rho (D) Immunoglobulin In Prevention of Hemolytic Disease Of Newborn. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BSV/Rh-ANTI D /13 (Version 1.0 dated 03 September 2013)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anahita R Chauhan 
Designation  Additional Professor & Unit Head 
Affiliation  Seth G. S. Medical College & KEM Hospital 
Address  Department of Obstetrics & Gynaecology, Seth G. S. Medical College & KEM Hospital,Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24107466  
Fax    
Email  anahitachauhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anahita R Chauhan 
Designation  Additional Professor & Unit Head 
Affiliation  Seth G. S. Medical College & KEM Hospital 
Address  Department of Obstetrics & Gynaecology, Seth G. S. Medical College & KEM Hospital,Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24107466  
Fax    
Email  anahitachauhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ms Naju Turakhia 
Designation  General Manager - Clinical Research 
Affiliation  Bharat Serums & Vaccines Limited 
Address  17th Floor, Hoechst House, Nariman Point

Mumbai
MAHARASHTRA
400021
India 
Phone  9987267718  
Fax  022-61383400  
Email  naju.turakhia@bharatserums.com  
 
Source of Monetary or Material Support  
Bharat Serums Vaccines Limited 
 
Primary Sponsor  
Name  Bharat Serums Vaccines Limited 
Address  17th Floor, Hoechst House, Nariman Point, Mumbai, Maharashtra, India - 400021 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yamini Trivedi  AMCMET Medical College & Sheth L.G. General Hospital  Department of Obstetrics & Gynaecology, AMCMET Medical College & Sheth L.G. General Hospital, Naninagar, Ahmedabad-380008
Ahmadabad
GUJARAT 		 079-25461382

yamilesh2@yahoo.com 
Dr Rashmi M D  Apollo BGS Hospital  Department of Obstetrics & Gynaecology, Apollo BGS Hospital, Kuvempunagar, Mysore-570023
Mysore
KARNATAKA 		 0821-2568888

drrashmimd@gmail.com 
Dr M D Rashmi  Apollo BGS Hospitals  Department of Obstetrics & Gynaecology, Apollo BGS Hospitals, Adichunchanagiri Road, Kuvempunagar, Mysore-570023 (India)
Mysore
KARNATAKA 		 8212466094

drrashmimd@gmail.com 
Dr Nilesh Shah  B J Medical College and Civil Hospital  Department of Obstetrics and Gynecology, B J Medical College and Civil Hospital, Ahmedabad 380008
Ahmadabad
GUJARAT 		 9825067627

nileshshah1953@gmail.com 
Dr Neelu Soni  Choithram Hospital & Research Centre  Department of Obstetrics & Gynaecology, Choithram Hospital & Research Centre, Manik Bagh Road, Indore – 452014
Indore
MADHYA PRADESH 		 0731-2470068

neelum30@hotmail.com 
Dr Partha Sarathi Chakravorty  IPGME&R/SSKM Hospital  Department of Obstetrics & Gynaecology, IPGME&R/SSKM Hospital, 244, A.J.C. Bose Road, Kolkata- 700020 (India)
Kolkata
WEST BENGAL 		 9830438955

parthasarathichakravorty@yahoo.co.in 
Dr Rekha Sachan  King George’s Medical University  Department of Obstetrics & Gynaecology, King George’s Medical University, Chowk, Lucknow - 226 003
Lucknow
UTTAR PRADESH 		 0522-2761249

drrekhasachan@gmail.com 
Dr Yogeshwar S Nandanwar  Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital  Department of Obstetrics & Gynaecology, L.T.M.M.C. & L.T.M.G.H., Sion, Mumbai - 400022
Mumbai
MAHARASHTRA 		 022-24063152

drnandanwar@hotmail.com 
Dr Trupti Nadkarni  Nowrosjee Wadia Maternity Hospital  Nowrosjee Wadia Maternity Hospital, Acharya Donde Marg, Parel, Mumbai- 400012 (India)
Mumbai
MAHARASHTRA 		 022-24146963

truptidp@rediffmail.com 
Dr Aruna Ramaiah  Osmania Medical College  Department of Obstetrics and Gynecology Modern Government Maternity Hospital, PetlaBurj, Hyderabad 500 064
Hyderabad
ANDHRA PRADESH 		 9490471022

dr.arunaramaiah@gmail.com 
Dr G V Paradkar  Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital  Department of Obstetrics & Gynaecology Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Kalwa, Thane – 400605
Thane
MAHARASHTRA 		 022-25347784

paradkar_g@rediffmail.com 
Dr Anahita R Chauhan  Seth G. S. Medical College & KEM Hospital  Department of Obstetrics & Gynaecology, Seth G. S. Medical College & KEM Hospital, Parel, Mumbai - 400012.
Mumbai
MAHARASHTRA 		 022-24107466

anahitachauhan@gmail.com 
Dr B S Meena  SMS Medical College and Attached Hospital  Department of Obstetrics and Gynecology, Mahila Chikitsalaya (Attached to SMS Medical College) Sanganeri Gate, Jaipur 302004
Jaipur
RAJASTHAN 		 9414041614

bhanwarsinghmina@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
AMC MET Ethics Committee  Approved 
Clinical Ethics Committee, Rajiv Gandhi Medical College & Chhatarpati Shivaji Maharaja Hospital  Approved 
Ethics Committee, Choitram Hospital and Research Center  Submittted/Under Review 
Institutional Ethics Committee I, Seth GS Medical College and KEM Hospital  Approved 
Institutional Ethics Committee, Apollo BSG Hospitals  Approved 
Institutional Ethics Committee, B J Medical College and Civil Hospital, Ahmedabad  Approved 
Institutional Ethics Committee, B. J. Medical College & Civil Hospital  Approved 
Institutional Ethics Committee, Government Medical College, Aurangabad  Approved 
Institutional Ethics Committee, Lokmanya Tilak Municipal Medical College  Approved 
Institutional Ethics committee-King Georges Medical University  Approved 
IPGME and R Research Oversight Committee  Submittted/Under Review 
Osmania Medical College-Institutional Ethics Committee  Approved 
The Ethics Committee, S.M.S Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O360||Maternal care for rhesus isoimmunization, Rh negative pregnant females delivering Rh positive baby.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Monoclonal anti Rho (D) immunoglobulin (Rhoclone®)  300 mcg of Monoclonal anti Rho (D) immunoglobulin (Rhoclone®) will be administered intramuscularly; postnatal within 72 hours of delivery. 
Comparator Agent  Polyclonal anti Rho (D) immunoglobulin (RhoGAM®)  300 mcg of Polyclonal anti Rho (D) immunoglobulin (RhoGAM®) will be administered intramuscularly; postnatal within 72 hours of delivery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Rh negative pregnant non-sensitised (negative indirect Coombs titre) women delivering live Rh positive infant.
2. Patients able to adhere to the study visit schedule and other protocol requirements
3. Subjects willing to participate in the study by giving written informed consent and permission to record the same on a video camera.
 
 
ExclusionCriteria 
Details  1. Rh negative women with husbands who are Rh negative.
2. Rh D positive or Rh D negative sensitised (positive indirect coombs titre) pregnant women with antibodies to Rh antigen.
3. Rh D negative women delivering Rh D negative infants.
4. Women with history of receiving incompatible blood transfusion.
5. Premature delivery prior to 36 weeks.
6. Women delivering stillborn baby.
7. Patients suffering from any medical condition that in the investigators opinion could compromise the patients ability to participate in the trial.
8. Women participating in another clinical trial in the four weeks before the screening visit.
9. History of anaphylactic or other severe systemic reaction to immunoglobulins.
10. Women with known history of IgA deficiency.
11. Women requiring blood transfusion after delivery. (If already randomized, such patients will be withdrawn from the study)
12. Women with Abruptio placentae, Placenta previa or IUD will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
No sensitization (negative indirect coomb’s test result)  72 hours, day 90 and day 180 post study drug administration 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Absence of antibodies against Monoclonal Rho Anti-D  at screening , post Monoclonal Rho Anti-D administration on day 90 and day 180  
Safety assessment  at screening, post study drug administration at 72 hours, day 90 and day 180  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/10/2015 
Date of Study Completion (India) 21/12/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 J Obstet Gynaecol India.2019 Oct;69(5):420-425. A Multicenter, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Monoclonal Anti-Rh (D) Immunoglobulin with Polyclonal Anti-Rh (D) Immunoglobulin for the Prevention of Maternal Rh-Isoimmunization  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
This was a prospective, randomized, open-label, phase III, multicentric study to assess prevention of Rh(D) immunization in Rh-negative women giving birth to Rh positive baby by administration of either the Test or Reference drug. The primary efficacy parameter in the study was absence of Rh(D) immunization (negative indirect Coombs test) at the end of the study

206 patients (101 in Reference vs 105 in Test group) enrolled in this study did not demonstrate difference at baseline parameters.

On day 180, 1 subject randomized to Rhogam® (Reference) versus none randomised to Rhoclone® (Test) group showed Positive ICT.

On day 180, negative ICT was reported in 89.5% in the Rhoclone® (Test) group and 86.1% in the Rhogam® (Reference) group with a p-value of 0.30  

5 Treatment-Emergent Adverse Events (TEAEs) were reported – 3 in Test versus 2 in Reference group. All TEAEs were unrelated to treatment administered.

Immunogenicity testing: No subject receiving Rhoclone® (Test) developed antibodies to Rhoclone® post administration of the drug.

 
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