A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/24/2019 |
| Start Date: | April 30, 2018 |
| End Date: | December 3, 2020 |
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
This study will look at how a known study medicine N8-GP works in previously N8-GP treated
people with haemophilia A. The aim is to look at how N8-GP works during regular use.
Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A
for several years. Participants will get an injection of N8-GP into a blood vessel, one, two
or three times weekly. Participants will get more doses if they bleed or if they will need a
surgery. The study will last for about 2 years. Participants will have at least 9 visits with
the study doctor. If participants agree to be in this study, they will get their first
injection (in this study) at the first visit. Participants will also get an injection at
visit 3, 5 and 7. Participants will be trained to give all other injections themselves.
Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood
thinners) during the study.
people with haemophilia A. The aim is to look at how N8-GP works during regular use.
Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A
for several years. Participants will get an injection of N8-GP into a blood vessel, one, two
or three times weekly. Participants will get more doses if they bleed or if they will need a
surgery. The study will last for about 2 years. Participants will have at least 9 visits with
the study doctor. If participants agree to be in this study, they will get their first
injection (in this study) at the first visit. Participants will also get an injection at
visit 3, 5 and 7. Participants will be trained to give all other injections themselves.
Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood
thinners) during the study.
Inclusion Criteria:
- Male patients of all ages with the diagnosis of severe congenital haemophilia A
(coagulation Factor VIII [FVIII] activity less than 1%) based on medical records
- On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at
the time of transfer
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
We found this trial at
19
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