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CTRI Number  CTRI/2025/11/096883 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to compare health outcomes of people with Haemophilia in India 
Scientific Title of Study   Outcome registry for Haemophilia patients in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Srivastava 
Designation  Senior Consultant, Department of Clinical Hematology 
Affiliation  St. Johns Medical College Hospital 
Address  Room No. 36, Silver Jubilee Block, Department of Clinical Hematology, St. John’s Medical College Hospital, Bengaluru.

Bangalore
KARNATAKA
560034
India 
Phone  08049467008  
Fax    
Email  alok.s@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Cecil Ross 
Designation  Professor and Head, Department of Clinical Hematology 
Affiliation  St. Johns Medical College Hospital 
Address  Room No. 36, Silver Jubilee Block, Department of Clinical Hematology, St. John’s Medical College Hospital, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  082149465481  
Fax    
Email  cecil.ross@stjohns.in  
 
Details of Contact Person
Public Query  
Name  Dr Cecil Ross 
Designation  Professor and Head, Department of Clinical Hematology 
Affiliation  St. Johns Medical College Hospital 
Address  Room No. 36, Silver Jubilee Block, Department of Clinical Hematology, St. John’s Medical College Hospital, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  082149465481  
Fax    
Email  cecil.ross@stjohns.in  
 
Source of Monetary or Material Support  
St. Johns Medical College Hospital 
 
Primary Sponsor  
Name  St. Johns Medical College Hospital 
Address  Sarjapura Road, John Nagar, Bengaluru, Karnataka - 560034, India.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alok Srivastava  St. Johns Medical College Hospital  Room No. 36, Silver Jubilee Block, Department of Clinical Hematology,Bengaluru.
Bangalore
KARNATAKA 		 08049467008

alok.s@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical College Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D67||Hereditary factor IX deficiency, (2) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  99.90 Year(s)
Gender  Both 
Details  Male or female participants diagnosed with Haemophilia A or B, with or without inhibitors confirmed by laboratory assays factor eight or nine deficiency.
Participants of all ages paediatric and adult.
Currently receiving either prophylaxis therapy or episodic therapy for at least 6 months prior to enrolment.
Willingness and ability to provide informed consent. If the participant is a minor consent will be obtained from the legal guardian and assent from the minor if appropriate.
Availability of medical records for the past six months to confirm the treatment history and clinical status. 
 
ExclusionCriteria 
Details  Patients with any other coagulopathies von Willebrand disease platelet dysfunction or bleeding disorders.
Patients who have undergone major surgery within the past three months and whose post-surgical care could confound study outcomes.
Patients unable or unwilling to comply with the study requirements or complete the full twelve month follow up period. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This is a non-interventional study. Study outcomes include comparison of clinical status of hemophilia patients on prophylaxis therapy versus those on episodic therapy.

 		 Baseline Three months, Six months and Twelve months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
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   N/A 
Date of First Enrollment (India)   20/11/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   India’s haemophilia care framework has been bolstered by provisions under the National Health Mission (NHM), which supplies clotting factor concentrates (CFCs) free of cost. However, despite this well-intentioned intervention, the supply of CFCs remains intermittent, and their distribution across regions is inconsistent. This leads to significant disparities in treatment access—most notably impacting patients in rural and economically disadvantaged communities. Such disparities not only hinder optimal clinical outcomes but also exacerbate financial and logistical burdens on patients and their families.The proposed study aims to address these critical gaps by analyzing cross-sectional and longitudinal data on haemophilia management in India. By examining clinical outcomes, treatment adherence, and quality of life across different patient groups, the research will generate data-driven insights essential for optimizing care models. Ultimately, the findings could drive policy recommendations that enhance the predictability of CFC supply, improve resource allocation, and ensure that all haemophilia patients receive equitable and effective treatment irrespective of their socioeconomic background. This study, therefore, represents a crucial step toward mitigating healthcare disparities and elevating the standard of haemophilia care in India. 
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