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CTRI Number  CTRI/2023/01/049204 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 09/06/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Non-interventional Study to Evaluate Bleeding Episodes and Treatment Use in Patients with Hemophilia 
Scientific Title of Study   A Global, Non-interventional Study to Prospectively Evaluate Bleeding Episodes and Treatment Use in Patients With Hemophilia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
157488  Other 
NCT05605678  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Ana Bapista 
Designation  Medical Director 
Affiliation  Syneos Health 
Address  Syneos Health, Lisbon, Portugal



1000-004
Other 
Phone    
Fax    
Email  ana.baptista@syneoshealth.com  
 
Details of Contact Person
Public Query  
Name  Jeevan Robero 
Designation  Sr. SSU and Regulatory Specialist 
Affiliation  Syneos Health 
Address  Syneos Health 3rd Floor, Tower B, Presidency Tower, 46/4, M. G. Road, Sector 14, Gurugram, Haryana-122001

Gurgaon
HARYANA
122001
India 
Phone  9620029341  
Fax    
Email  jeevan.robero@syneoshealth.com  
 
Source of Monetary or Material Support  
ApcinteX Ltd, 1 Ashley Road, 3rd Floor Altrincham Cheshire WA14 2DT UnitedKingdom 
 
Primary Sponsor  
Name  ApcinteX Ltd 
Address  1 Ashley Road, 3rd Floor Altrincham Cheshire WA14 2DT United Kingdom 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Armenia
Australia
Brazil
Canada
Egypt
Italy
Poland
Spain
Taiwan
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Joseph John  Christian Medical College and Hospital,  Department of Clinical Haematology, Haemato-oncology & Bone Marrow (Stem cell) Transplantation, Brown Road, Ludhiana- 141008, Punjab, India
Ludhiana
PUNJAB 		 8054959525

mjosephjohn@cmcludhiana.in 
Dr Savita Rangarajan  K J Somaiya Super Speciality Hospital & Research Centre  Somaiya Ayurvihar Complex, Eastern Express Highway, Sion (East), Mumbai- 400022, Maharashtra, India
Mumbai
MAHARASHTRA 		 9619525341

rangarajansavita@gmail.com 
Dr Cecil Ross Reuben  St. Johns Medical College  Sarjapur Road Bangalore, Karnataka, 560034, India
Bangalore
KARNATAKA 		 9448493705

cecil.ross@stjohns.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee- Christian Medical College  Approved 
Institutional Ethics Committee- K J Somaiya Hospital  Approved 
Institutional Ethics Committee- St. Johns Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D683||Hemorrhagic disorder due to circulating anticoagulants,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1. Male patients ≥12 and ≤65 years of age
2. Capable of providing written informed consent (adolescent assent and parental/guardian consent when appropriate) for participation after reading the information and consent form and having the opportunity to discuss the study with the Investigator or their designee
3. Historically documented severe HemA (defined as FVIII <0.01 IU/mL [<1%]), with or without inhibitors, or moderately severe to severe HemB (defined as FIX ≤0.02 IU/mL [≤2%]) without inhibitors. Patients must be currently included in a prophylactic treatment program or if undergoing an on-demand treatment regimen must have had ≥6 documented acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months before enrollment
OR: Historically documented HemB (defined as FIX ≤0.05 IU/mL [≤5%]) with inhibitors with a historical or ongoing high-titer inhibitor [≥5 Bethesda Units/mL] based on medical records or laboratory reports) and an ABR of ≥6 in the 6 months before enrollment
4. Able to use a diary to document bleeding events and treatment 
 
ExclusionCriteria 
Details  1. Known thrombophilia
2. Body weight >150 kg or body mass index >40
3. Known current inadequate hematologic function (eg, platelet count <100,000/uL and/or hemoglobin level <10 g/dL, <100 g/L), hepatic function (ie, total bilirubin >1.5 x upper limit of normal [ULN] [excluding Gilbert syndrome], aspartate transferase and/or alanine aminotransferase levels >3 x ULN; clinical signs or known laboratory or radiographic evidence consistent with cirrhosis of the liver) or renal function (ie, serum creatinine >2 x ULN; based on medical records or available laboratory reports)
4. Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or stroke
5. History of intolerance to subcutaneous injections
6. Known current uncontrolled hypertension (systolic blood pressure >160 mm Hg; diastolic blood pressure >100 mm Hg; based on medical records)
7. Active cancer or requires therapy for cancer, except for basal cell carcinoma
8. Concurrent participation in an interventional clinical trial
9. Current or planned use of emicizumab
10. Prior, ongoing, or planned treatment with gene therapy for hemophilia
11. History of or other evidence of recent alcohol or drug abuse as determined by the Investigator or their designee (in the 12 months before enrollment)
12. Known HIV infection with CD4 count (or T-cell count) of <200 cells/μL within 24 weeks before enrollment
13. Current or planned treatment with anticoagulant or antiplatelet drugs
14. Any other significant conditions or comorbidities that, in the opinion of the Investigator 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Annualized Bleeding Rate (ABR) for Treated Bleeds and All Bleeds  Minimum 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Average Dose (IU/kg) of Associated Treatment Received for Bleeding Episodes per Hemophilia Product per Time Period and per Bleeding Episode  Minimum 12 weeks  
 
Target Sample Size   Total Sample Size="200"
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   N/A 
Date of First Enrollment (India)   01/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/02/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The primary objective of this study is to obtain prospective baseline documentation of annualized bleeding rates (ABRs) and treatment under standard-of-care (SOC) therapy among participants with hemophilia A or B. Participants in the study may be eligible to enroll in future planned interventional studies to be conducted by Sponsor. 
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