Clinical Trials List
Protocol NumberNN7088-4410
NCT Number(ClinicalTrials.gov Identfier)NCT03528551
2018-05-01 - 2021-05-20
Phase III
Terminated1
ICD-10D66
Hereditary factor VIII deficiency
ICD-9286.0
Congenital factor VIII disorder
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A
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Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
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Sponsor
Novo Nordisk A/S
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Haemophilia A
Objectives
Primary objective
To investigate the safety of turoctocog alfa pegol during continuous use for prevention and
treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia
A patients.
Secondary objectives
To investigate the following in severe haemophilia A patients previously treated with
turoctocog alfa pegol
Development of FVIII inhibitors
Efficacy of turoctocog alfa pegol prophylaxis
Haemostatic efficacy of turoctocog alfa pegol when used for treatment of bleeds
Test Drug
turoctocog alfa pegol (N8-GP)
Active Ingredient
Glycopegylated recombinant coagulation factor VIII
Dosage Form
injection
Dosage
2000U/vial (211 µg/vial)
Endpoints
1. Primary Endpoints
Number of adverse events reported
2. Secondary Endpoints
Incidence of FVIII inhibitors ≥0.6 BU
Number of bleeding episodes on prophylaxis
Number of spontaneous bleeding episodes on prophylaxis
Haemostatic effect of turoctocog alfa pegol when used for treatment of bleeding episodes
assessed as: Excellent, Good, Moderate, or None
Number of turoctocog alfa pegol injections required per bleeding episode
Number of adverse events reported
2. Secondary Endpoints
Incidence of FVIII inhibitors ≥0.6 BU
Number of bleeding episodes on prophylaxis
Number of spontaneous bleeding episodes on prophylaxis
Haemostatic effect of turoctocog alfa pegol when used for treatment of bleeding episodes
assessed as: Excellent, Good, Moderate, or None
Number of turoctocog alfa pegol injections required per bleeding episode
Inclution Criteria
Key inclusion criteria
Male patients of all ages with the diagnosis of severe congenital haemophilia A (FVIII activity <1%) based
on medical records
On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of
transfer
Male patients of all ages with the diagnosis of severe congenital haemophilia A (FVIII activity <1%) based
on medical records
On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of
transfer
Exclusion Criteria
Key exclusion criteria
Known or suspected hypersensitivity to trial product including allergy to hamster protein or related
products
Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might
jeopardise patient’s safety or compliance with the protocol
Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885
(pathfinder5)) of an approved or non-approved investigational medicinal product
Known or suspected hypersensitivity to trial product including allergy to hamster protein or related
products
Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might
jeopardise patient’s safety or compliance with the protocol
Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885
(pathfinder5)) of an approved or non-approved investigational medicinal product
The Estimated Number of Participants
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Taiwan
3 participants
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Global
170 participants
