Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)

  • STATUS
    Recruiting
  • End date
    Feb 25, 2023
  • participants needed
    36
  • sponsor
    Novo Nordisk A/S
Updated on 9 December 2021

Summary

The study investigates how well the medicine called turoctocog alfa pegol (N8-GP) works in previously treated Chinese patients with severe haemophilia A.

Participants will be treated with N8-GP. This is a medicine that doctors can already prescribe in other countries.

The medicine will be injected into a vein (intravenous injections) and blood samples will be collected.

The study will last for about 7-8 months. Participants will have between 8 and 15 visits to the clinic and possibly a number of phone calls with the study doctor.

Details
Condition hema, Hemophilia A, Hemophilia
Treatment Turoctocog alfa pegol (N8-GP)
Clinical Study IdentifierNCT05082116
SponsorNovo Nordisk A/S
Last Modified on9 December 2021

Eligibility

Yes No Not Sure

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 Chinese patient with severe congenital haemophilia A with a FVIII activity below 1% according to medical records
Aged greater than or equal to 12 years at the time of signing informed consent
History of at least 150 exposure days (EDs) to other FVIII products
The patient and/or caregiver is capable of assessing a bleeding episode, keeping a diary, performing home treatment of bleeding episodes and otherwise following the trial procedures at the discretion of the investigator

Exclusion Criteria

Known or suspected hypersensitivity to trial product or related products
Previous participation in this trial. Participation is defined as signed informed consent
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 5 half-lives or 30 days from screening, whichever is longer
Known history of FVIII inhibitors based on existing medical records, laboratory report reviews and patient and/or caregiver interviews
Current FVIII inhibitors greater than or equal to 0.6 BU
Congenital or acquired coagulation disorder other than haemophilia According to medical records
HIV positive, defined by medical records, with CD4+ count less than or equal 200/L and a viral load greater than 200 particles/l or greater than 400000 copies/mL within 6 months of the trial entry. If the data are not available in medical records within last 6 months, then the test must be performed at screening visit
Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records
Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 3 times limit of normal combined with total bilirubin greater than 1.5 times the upper limit of normal at screening, as defined by central laboratory
Renal impairment defined as estimated glomerular filtration rate (eGFR) below or equal to 30 mL/min/1.73 m^2 for serum creatinine measured at screening, as defined by central laboratory
Platelet count below 50109/L at screening based on central laboratory values at screening
Ongoing immune modulating or chemotherapeutic medication
Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise the patient's safety or compliance with the protocol
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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