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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 February 2019
Main ID:  NCT03528551
Date of registration: 18/04/2018
Prospective Registration: Yes
Primary sponsor: Novo Nordisk A/S
Public title: A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A pathfinder8
Scientific title: 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
Date of first enrolment: April 30, 2018
Target sample size: 173
Recruitment status: Enrolling by invitation
URL:  https://clinicaltrials.gov/show/NCT03528551
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Australia Brazil Canada Croatia Denmark France Germany Greece
Hungary Israel Italy Japan Korea, Republic of Lithuania Malaysia Netherlands
Norway Portugal Puerto Rico Spain Switzerland Taiwan Turkey Ukraine
United Kingdom United States
Contacts
Name:     Clinical Reporting Anchor and Disclosure 1452
Address: 
Telephone:
Email:
Affiliation:  Novo Nordisk A/S
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Male
Health Condition(s) or Problem(s) studied
Congenital Bleeding Disorder
Haemophilia A
Intervention(s)
Drug: Turoctocog alfa pegol
Primary Outcome(s)
Number of adverse events reported [Time Frame: Weeks 0-104]
Secondary Outcome(s)
Change from start till end of trial in treatment satisfaction (based on Hemo-SAT score) [Time Frame: Week 0, Week 104]
Change in joint health status from start to end of trial (based on Haemophilia Joint Health Score) [Time Frame: Week 0, Week 104]
Consumption of N8-GP during prophylaxis treatment [Time Frame: Weeks 0-104]
Consumption of N8-GP per bleed [Time Frame: Weeks 0-104]
Haemostatic effect of N8-GP when used for treatment of bleeding episodes assessed as: Excellent, Good, Moderate, or None [Time Frame: Weeks 0-104]
Haemostatic response during major surgical interventions assessed as: Excellent, Good, Moderate, or None [Time Frame: Weeks 0-104]
Incidence of FVIII inhibitors =0.6 BU [Time Frame: Weeks 0-104]
Number of bleeding episodes on prophylaxis [Time Frame: Weeks 0-104]
Number of N8-GP injections required per bleeding episode [Time Frame: Weeks 0-104]
Number of spontaneous bleeding episodes on prophylaxis [Time Frame: Weeks 0-104]
Pre-dose FVIII activity levels on N8-GP prophylaxis (IU/dL) [Time Frame: Weeks 0-104]
Secondary ID(s)
2017-003788-36
JapicCTI-183952
NN7088-4410
U1111-1202-2780
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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