Clinical Trials List
Protocol NumberNN7769-4514
NCT Number(ClinicalTrials.gov Identfier)NCT
Completed
2021-12-02 - 2025-04-11
Phase III
Not yet recruiting1
Recruiting2
ICD-10D66
Hereditary factor VIII deficiency
ICD-9286.0
Congenital factor VIII disorder
A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors
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Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
Sponsors
Co-Principal Investigator
- 王德明 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Haemophilia A
Objectives
Primary objectives
To confirm the haemostatic effect of Mim8 as treatment prophylaxis for adult and adolescent
patients with haemophilia A with or without inhibitors.
Secondary objectives
To investigate safety of Mim8 prophylaxis in adults and adolescents with haemophilia A with or
without FVIII inhibitors.
To evaluate the consumption of factor product per bleed treatment (number of injections) after
Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
To evaluate the development of anti-Mim8 antibodies after Mim8 prophylaxis in adults and
adolescents with haemophilia A with or without inhibitors.
Test Drug
Mim8
Active Ingredient
Mim8
Dosage Form
Solution for injection
Dosage
10 mg/ml; 100 mg/ml
Endpoints
1.No prophylaxis treatment (Arms 1 and 2):
From randomisation (week 0) to end of main (Week 26)
2.Prophylaxis treatment (Arms 3 and 4):
From initiation of run-in (26-52 weeks prior to week 0) to
week 0 and from randomisation (week 0) to end of main
(Week 26)
From randomisation (week 0) to end of main (Week 26)
2.Prophylaxis treatment (Arms 3 and 4):
From initiation of run-in (26-52 weeks prior to week 0) to
week 0 and from randomisation (week 0) to end of main
(Week 26)
Inclution Criteria
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2. Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
3. Patient has been prescribed, or in need of, treatment with factor VIII or bypassing agent in the last 26 weeks prior to screening
4. Age above or equal to 12 years at the time of signing informed consent.
5. Body weight ≥30 kg
6. Applicable to patients on emicizumab prophylaxis: patient is willing to discontinue emicizumab at the time of screening
7. Applicable to patients treated on-demand/with no prophylaxis: ≥5 bleeds in the last 26 weeks prior to screening visit
8. Applicable to patients with FVIII activity >1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit
9. Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires
2. Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
3. Patient has been prescribed, or in need of, treatment with factor VIII or bypassing agent in the last 26 weeks prior to screening
4. Age above or equal to 12 years at the time of signing informed consent.
5. Body weight ≥30 kg
6. Applicable to patients on emicizumab prophylaxis: patient is willing to discontinue emicizumab at the time of screening
7. Applicable to patients treated on-demand/with no prophylaxis: ≥5 bleeds in the last 26 weeks prior to screening visit
8. Applicable to patients with FVIII activity >1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit
9. Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires
Exclusion Criteria
1. Previous participation in this trial. Participation is defined as signed informed consent
2. Participation in any clinical trial of an approved or non-approved investigational medicinal product, within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period
4. Any disorder, except for conditions associated with haemophilia A, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
5. Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products
6. Receipt of gene therapy at any given time point
7. Ongoing or planned ITI therapy
8. Major surgery planned at the time of screening.
9. Known congenital or acquired coagulation disorders other than haemophilia A
10. Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening
11. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) ≤30 ml/min/1.73 m2 for serum creatinine measured at screening
12. Previous or current thromboembolic disease or eventsa(with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator
13. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
14. Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator
2. Participation in any clinical trial of an approved or non-approved investigational medicinal product, within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period
4. Any disorder, except for conditions associated with haemophilia A, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
5. Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products
6. Receipt of gene therapy at any given time point
7. Ongoing or planned ITI therapy
8. Major surgery planned at the time of screening.
9. Known congenital or acquired coagulation disorders other than haemophilia A
10. Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening
11. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) ≤30 ml/min/1.73 m2 for serum creatinine measured at screening
12. Previous or current thromboembolic disease or eventsa(with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator
13. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
14. Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator
The Estimated Number of Participants
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Taiwan
4 participants
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Global
267 participants
