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CTRI Number  CTRI/2024/02/062683 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 03/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A research study looking at long-term treatment with Mim8 in people with haemophilia A  
Scientific Title of Study   Open-label, long-term safety and efficacy study of Mim8 in participants with haemophilia A with or without inhibitors 
Trial Acronym  NN7769-4532 (FRONTIER 4) 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2022-502215-10-00  EudraCT 
NN7769-4532 Protocol v6.0 dated 10 Jul 2025  Protocol Number 
U1111-1274-4426  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Pvt. Ltd. 
Address  Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India

Bangalore
KARNATAKA
560045
India 
Phone  9911497869  
Fax    
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Pvt. Ltd. 
Address  Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India

Bangalore
KARNATAKA
560045
India 
Phone  9911497869  
Fax    
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support
Modification(s)  
Novo Nordisk A/S , Novo Allé, 2880 Bagsvaerd, Denmark  
 
Primary Sponsor
Modification(s)  
Name  Novo Nordisk India Private Limited 
Address  Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India Tel No.: 080-40303200  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Austria
Belgium
Bulgaria
Canada
China
Denmark
France
Germany
India
Ireland
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
Poland
Portugal
Republic of Korea
Romania
Saudi Arabia
Serbia
Slovakia
South Africa
Spain
Switzerland
Taiwan
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 7  
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 and Bone Marrow (Stem Cell) Transplantation, 4th Floor, BMT Office, Brown Road, CMC Campus, PIN - 141008
Ludhiana
PUNJAB 		 8054959525

mjosephjohn@cmcludhiana.in 
Dr Aby Abraham  Christian Medical College Vellore   Department of Haematology, Christian Medical College Vellore- Ranipet Campus, Kilminnal Village, Ranipet, PIN - 632 517
Vellore
TAMIL NADU 		 04172224553

aby@cmcvellore.ac.in 
Dr Kapil Garg  J K Lon Hospital  Department of Paediatrics, J K Lon Hospital, Attached to SMS College, PIN - 302004
Jaipur
RAJASTHAN 		 9829182888

drkapilgargjkl@gmail.com 
Dr Nirmalkumar Ganeshmal Choraria  Nirmal Hospital Pvt. Ltd.   Clinical Research Department, Ring Road, PIN -395002
Surat
GUJARAT 		 9979530073

drnirmalchoraria@gmail.com 
Dr Nita Radhakrishnan   Post Graduate Institute of Child Health  Department of Paediatric Haematology-Oncology, Sector 30, Noida, PIN - 201303
Gautam Buddha Nagar
UTTAR PRADESH 		 9999041524

nitark@gmail.com 
Dr Shashikant Apte   Sahyadri Super Speciality Hospital  Department of Haematology, 7th Floor, 30 C, Erandwane, Karve Road, PIN - 411004
Pune
MAHARASHTRA 		 9822404983

shashikant.apte@gmail.com 
Dr Chandrakala S  Seth GS Medical College and KEM Hospital  Department of Haematology, Parel, PIN - 400012
Mumbai
MAHARASHTRA 		 9699087654

drchandra1s@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee SMS Medical college and Attached Hospital, J LN Marg, Jaipur, Rajasthan-302004, India  Approved 
Institutional Ethics Committee (IEC)-I, New UG-PG Hostel, 20 Storey Hostel Building, Ground Floor, Seth G. S. Medical College & K. E. M Hospital, Parel, Mumbai – 400012, India   Approved 
Institutional Ethics Committee, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab- 141008, India   Approved 
Institutional Ethics Committee, Super specialty Pediatric Hospital and PGTI SSPHPGTI, Sector 30, Noida Gautam Buddha Nagar, Uttar Pradesh - 201303, India   Approved 
INSTITUTIONAL REVIEW BOARD , CHRISTIAN MEDICAL COLLEGE THORAPADI POST BAGAYAM VELLORE Vellore Tamil Nadu - 632012   Approved 
Nirmal Hospital Pvt. ltd. Ethics Committee, Nirmal Hospital Pvt. ltd. Ring Road, Near Centre point, Surat-395002, Gujarat, India.  Approved 
Sahyadri Hospitals PVT Ltd Ethics Committee, Sahyadri clinical research & Development Centre, A unit of Sahyadri Hospital Private Ltd, 33/34B, Makarand Bhave Path, Erandwane, Pune -411004, Maharashtra, India.  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  NNC0365-3769 B (Mim8)  Pharmaceutical form: DV3407 pen-injector, Solution for injection; Route of administration: Subcutaneous; Trial product strength: 2.0 mg/mL, 5.0 mg/mL, 11.3 mg/mL, 25.0 mg/mL, 57.5 mg/mL; Dose and dose frequency: Only maintenance doses are administered. Dose frequency is either once-weekly, once every 2 weeks, or once monthly. Dose is set based on weight bands. 
 
Inclusion Criteria
Modification(s)  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female with diagnosis of congenital haemophilia A based on medical records.
3. Ongoing participation in study 4513, 4514, 4516, or 4728 at the time of transfer. Participant should qualify either of the following criteria:
a. Participant from study 4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study 4532, or,
b. Participant has completed the end of treatment visit for study 4514,4516, or 4728.
4. Participant and/or participants parent(s)/participants LAR willingness and ability to comply with scheduled visits and study procedures, including the completion of diary.
 
 
ExclusionCriteria 
Details  1. Any disorder, except for conditions associated with haemophilia, which in the investigators opinion might jeopardise participants safety or compliance with the protocol.
2. Participant who has discontinued or been withdrawn from studies 4513, 4514, 4516, or 4728.
3. Previous participation in this study. Participation is defined as signed informed consent.
4. Female who is pregnant, breast-feeding or intends to become pregnant.
5. Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures as defined in Appendix 4 or as required by local regulation or
practice).
6. Participation (i.e., signed informed consent) in any other interventional clinical study (except from study 4513, 4514, 4516, or 4728) of an approved or non-approved investigational medicinal product.
7. Any planned major surgery, during part 1 of the study.
8. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
 
 
Method of Generating Random Sequence
Modification(s)  		 Computer generated randomization 
Method of Concealment
Modification(s)  		 Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of
treatment-emergent adverse events 		 From Visit 1 (week 0) until end
of study (up to 283 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Number of injection site reactions  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Occurrence of anti-Mim8 antibodies  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Number of treated bleeding episodes  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Number of treated spontaneous
bleeding episodes 		 From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Number of treated traumatic bleeding episodes  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Number of treated joint bleeding
episodes 		 From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Number of treated target joint bleeding episodes (Arm 2)  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Mim8 plasma concentration  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Device handling experience using HDAT (applicable for participants in Arm 2 only)  At Visit 8 (week 26) & Visit
10 (week 52) 
Change in participants’ treatment burden using the Hemo-TEM (Applicable for participants in Arm 2 only excluding Chinese participants)  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Change in participant’s joint pain score using JPRS (Applicable for adult & adolescent participants in Arm 2 only excluding Chinese participants)  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
Change in physical function domain of PedsQL Generic Core Scales (Applicable for participants in Arm 2 only excluding Chinese participants)  From Visit 1 (week 0) until end
of treatment (up to 262 weeks) 
 
Target Sample Size   Total Sample Size="425"
Sample Size from India="19" 
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)
Modification(s)  		 29/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/02/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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
Modification(s)  
This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often the participants will receive Mim8 in this study depends on the treatment participant receives in the current Mim8 study participant is taking part in. The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participants country during the study, or the study will end in 2028, whichever comes first. Mim8 will be injected under the skin with a thin needle either once a week, once every two weeks or once a month. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.
 
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