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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994407
Other study ID # NN7170-4213
Secondary ID U1111-1183-51112
Status Completed
Phase Phase 1
First received
Last updated
Start date January 30, 2017
Est. completion date October 15, 2018

Study information

Verified date January 2020
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 15, 2018
Est. primary completion date October 15, 2018
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Male, age above or equal to 18 years at the time of signing informed consent,(part A).

- Male, age above or equal to 12 years at the time of signing informed consent,(part B).

- Diagnosis of congenital haemophilia A based on medical records (FVIII activity <1%).

- History of more than 150 exposure days to any FVIII containing products.

Exclusion Criteria:

- Previous participation in this trial. Participation is defined as signed informed consent.

(Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)

- Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/µL performed at screening or defined by medical records no older than 6 months)

- Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)

- Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.

Study Design


Intervention

Drug:
turoctocog alfa pegol
Part A: Participants will receive a single dose of turoctocog alfa pegol, administered subcutaneously (under the skin), at a dose of 12.5, 25 or 50 U/kg. Part B: Participants will receive a daily dose of turoctocog alfa pegol, as identified in Part A, as a subcutaneous (under the skin) injection for a period of 3 months.

Locations

Country Name City State
Austria Novo Nordisk Investigational Site Innsbruck
Austria Novo Nordisk Investigational Site Wien
France Novo Nordisk Investigational Site Nantes Cedex 1
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Duisburg
Germany Novo Nordisk Investigational Site Homburg
Japan Novo Nordisk Investigational Site Shinjuku-ku, Tokyo
Japan Novo Nordisk Investigational Site Tokyo
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Novi Sad
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Cleveland Ohio
United States Novo Nordisk Investigational Site Dayton Ohio
United States Novo Nordisk Investigational Site East Lansing Michigan
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site Norfolk Virginia
United States Novo Nordisk Investigational Site Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Japan,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events Count and % of Adverse events Day 0-Day 28
Secondary Cmax Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Incidence of FVIII inhibitors above or equal to 0.6 BU Count of presence of inhibitors Day 0-Day 28
Secondary Area under the activity time curve from 0 to infinity Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Area under the activity time curve from 0 to t Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Area under the activity time curve from 0 to last Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary tmax- time to maximal FVIII activity Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Cmin -the minimal FVIII activity Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary tmin - time to minimal FVIII activity Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Css, min - the minimum FVIII activity at steady state Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Css, max - the maximal FVIII activity at steady state Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Css - the mean FVIII activity at steady state Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Racc - accumulation ratio Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary t½ - terminal half-life Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary CL - total plasma clearance of drug after intravenous administration Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Vz -apparent volume of distribution during terminal phase Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Vss - apparent volume of distribution during steady state Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary MRT - mean residence time Calculated based on plasma FVIII activity measured in blood. 0-144 hours
Secondary Injection site reactions Count of reactions Day 0 - day 28
Secondary Number of treatment requiring bleeding episodes Count of episodes Day 0 - day 120
Secondary Consumption of FVIII Measured in IU Day 0 - day 120
Secondary Change in Coagulation parameters, fibrinogen Measured in g/L Day 0, day 7
Secondary Change in Coagulation parameters, antithrombin Measured in % Day 0, day 7
Secondary Change in Coagulation parameters, international normalised ratio Measured in INR Day 0, day 7
Secondary Change in Coagulation parameters, activated partial thromboplastin time Measured in sec. Day 0, day 7
Secondary Change in Coagulation parameters, von Willebrand Factor Measured in % Day 0, day 7
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