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CTRI Number  CTRI/2024/10/076005 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Other 
Public Title of Study   Study of Nuwiq Use for Surgery in Patients with Haemophilia A Already on Regular Treatment with Emicizumab  
Scientific Title of Study   Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GENA 22, Version 4.0 dated 20 Oct 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siva Subramanian 
Designation  VP Corporate Services Global Head DM and CM India 
Affiliation  Allucent India Pvt Ltd 
Address  Unit No 602 6th Floor RMZ Ecoworld Campus 31 Sarjapur Marathhalli Out Ring Road DevaraBeesanahalli Village Varthur Hobli Bengaluru Karnataka

Bangalore
KARNATAKA
560103
India 
Phone  91806712222  
Fax  91806712222  
Email  Siva.Subramanian@allucent.com  
 
Details of Contact Person
Scientific Query  
Name  Siva Subramanian 
Designation  VP Corporate Services Global Head DM and CM India 
Affiliation  Allucent India Pvt Ltd 
Address  Unit No 602 6th Floor RMZ Ecoworld Campus 31 Sarjapur Marathhalli Out Ring Road DevaraBeesanahalli Village Varthur Hobli Bengaluru Karnataka


KARNATAKA
560103
India 
Phone  91806712222  
Fax  91806712222  
Email  Siva.Subramanian@allucent.com  
 
Details of Contact Person
Public Query  
Name  Siva Subramanian 
Designation  VP Corporate Services Global Head DM and CM India 
Affiliation  Allucent India Pvt Ltd 
Address  Unit No 602 6th Floor RMZ Ecoworld Campus 31 Sarjapur Marathhalli Out Ring Road DevaraBeesanahalli Village Varthur Hobli Bengaluru Karnataka


KARNATAKA
560103
India 
Phone  91806712222  
Fax  91806712222  
Email  Siva.Subramanian@allucent.com  
 
Source of Monetary or Material Support  
Allucent (India) Private Limited, No. 15, KMJ Arcadia, I Floor, Industrial Main Road Koramangala, 5th Block, Bengaluru (India) - 560095. 
 
Primary Sponsor  
Name  Allucent India Private Limited 
Address  Allucent (India) Private Limited, No. 15, KMJ Arcadia, I Floor, Industrial Main Road Koramangala, 5th Block, Bengaluru (India) - 560095. 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
Allucent India Private Limited  No. 15, KMJ Arcadia, I Floor, Industrial Main Road Koramangala, 5th Block, Bengaluru (India) - 560095. 
 
Countries of Recruitment     India
Croatia
Finland
France
Germany
Italy
Macedonia
Serbia
Spain
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aby Abraham  Christian Medical College  Dept of Haematology A Block 5th Floor Kilminnal Village, Ranipet District, Tamil Nadu, India 632517
Vellore
TAMIL NADU 		 914172224553
914172224553
aby@cmcvellore.ac.in 
Dr Alok Srivastava  St. John’s Medical College Hospital  Department of Clinical Haematology, St. John’s Medical College Hospital, Bengaluru, 560034, India
Bangalore
KARNATAKA 		 918022065481

asriv@haematology.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not applicable 
Intervention  Nuwiq  Prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis.Nuwiq will be administered intravenously. Dosing will be calculated based on the desired FVIII plasma levels as follows: The required pre- and post-operative FVIII plasma levels are 80–100 international units (IU)/dL. Treatment will be repeated as necessary every 8–24 hours until adequate wound healing, then – if required – for at least another 7 days to maintain FVIII plasma levels of 30–60 IU/dL.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  1)Severe haemophilia A (FVIII activity [FVIII:C] less than 1%) according to medical history
2)Male patients at least 12 years of age
3)Previous treatment with any FVIII product(s) for at least 150 exposure days
4)On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment
5)Freely given written informed consent of the patient, or parent or legal representative where applicable, obtained in accordance with local regulations
Surgery is defined as major if any of the following criteria are met:
Requiring general or spinal anaesthesia
Requiring opening into the great body cavities
Orthopaedic interventions involving joints (ankle, knee, hip, wrist, elbow, shoulder)
Surgeries or conditions in which the patients life is at stake
 
 
ExclusionCriteria 
Details  1)Coagulation disorder other than haemophilia A 2)Present or past FVIII inhibitor (morethan or equal to 0.6 Bethesda units [BU]per mL) according to medical history
3)Severe liver or kidney disease (alanine aminotransferase [ALT] and or aspartate
aminotransferase [AST] levels more than 5 times the upper limit of normal; or creatinine more than 120 μmolperL)
4)Known hypersensitivity to Nuwiqs active substance or its excipients (sucrose,
sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
5)Already had surgery in this study
6)Current participation in another interventional clinical trial
7)Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The overall haemostatic efficacy of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery. Efficacy will be assessed at the end of surgery by the surgeon and at the end of the POP (up to 24 hours after the last injection of Nuwiq) by the investigator (haematologist) using a 4 point ordinal haemostatic efficacy scale. Overall haemostatic efficacy will be adjudicated by the Independent Data Monitoring Committee using a predefined algorithm.   During surgery and up to 24 hours after last injection of Nuwiq  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary endpoints of this study are:
1) Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4 point ordinal scale
2) Assessment of postoperative haemostatic efficacy of Nuwiq using a 4 point ordinal scale
3) Number of allogeneic blood products (red blood cells, platelets, & other blood products) transfused.
4) Perioperative FVIII plasma levels immediately before & after Nuwiq injections
5) Perioperative TG immediately before & after Nuwiq injections
6) Perioperative haemostatic efficacy assessed using the 4 point scale recommended by the WFH
7) Incidence of adverse events (AEs)
8) Incidence of thrombotic events
9) Incidence of FVIII inhibitor formation

 		 1) During surgery: From first skin incision to last suture
2) From end of surgery until 24 hours after the last injection of Nuwiq
3) From day of surgery until 24 hours after the last injection of Nuwiq
4) Less than 30 minutes before & less than 30 minutes after Nuwiq injection
5) Less than 30 minutes before & less than 30 minutes after Nuwiq injection
6) Perioperative
7) 8) 9) From start of first Nuwiq injection to 30 days following the surgical procedure
 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="15" 
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)   30/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/11/2023 
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)   Open to Recruitment 
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   "Patients with severe haemophilia A receiving emicizumab will often need concomitant FVIII to provide haemostatic cover during major surgery. This prospective, open-label, uncontrolled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq, a recombinant factor VIII, in combination with emicizumab prophylaxis in male patients over 12 with severe haemophilia A undergoing major surgery

 In the absence of neutralising FVIII inhibitors, haemostatic cover can be provided with concomitant FVIII. However, prospective data on the efficacy and safety of concomitant use of FVIII and emicizumab from clinical trials are limited. 
 
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