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Clinical trial

An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

ID
Name
NN7088-3908
Description
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
Trial arms
Trial start
2014-06-26
Estimated PCD
2023-06-07
Trial end
2023-06-07
Status
Completed
Phase
Early phase I
Treatment
turoctocog alfa pegol
For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis
Arms:
50 EDs (exposure days)
Other names:
NNC 0129-0000-1003, N8-GP
Size
125
Primary endpoint
Incidence of inhibitory antibodies against coagulation factor VIII (FVIII)
When the first 50 PUP have reached at least 50 exposure dates. (Expected to reach between 6 - 18 months)
Incidence of inhibitory antibodies against coagulation factor VIII (FVIII)
At the end of the trial. End of trial will be up to 4 years after the patient has reached 100 exposure dates. (Expected to reach between 12 - 60 months)
Eligibility criteria
Inclusion Criteria: * 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 * Male, age below 6 years of age at the time of signing informed consent * Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results * No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable) Exclusion Criteria: * Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products * Previous participation in this trial. Participation is defined as first dose administered of trial product * Receipt of any investigational medicinal product within 30 days before screening * Congenital or acquired coagulation disorder other than haemophilia A * Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol * Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 125, 'type': 'ESTIMATED'}}
Updated at
2024-04-26

1 organization

1 product

2 indications

Organization
Novo Nordisk
Product
Turoctocog Alfa Pegol
Indication
Congenital Bleeding Disorder
Indication
Hemophilia A