Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Ep… (NCT05082116) | Clinical Trial Compass
CompletedPhase 3
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)
China36 participantsStarted 2021-09-27
Plain-language 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.
Who can participate
Age range12 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Number of Bleeding Episodes Per Year (Annualised Bleeding Rate)
Timeframe: From start of treatment (Week 0) until Week 28