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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01205724
Other study ID # NN7088-3776
Secondary ID 2010-018520-68U1
Status Completed
Phase Phase 1
First received September 17, 2010
Last updated February 9, 2017
Start date September 2010
Est. completion date April 2011

Study information

Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Haemophilia A

- Body Mass Index (BMI) below 35 kg/m2

- History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)

Exclusion Criteria:

- Any history of FVIII inhibitors

- Surgery planned to occur during the trial

- Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)

- Congenital or acquired coagulation disorders other than haemophilia A

Study Design


Intervention

Drug:
turoctocog alfa pegol
Single dose (low) administered intravenously (into the vein)
turoctocog alfa pegol
Single dose (medium) administered intravenously (into the vein)
turoctocog alfa pegol
Single dose (high) administered intravenously (into the vein)

Locations

Country Name City State
Germany Novo Nordisk Investigational Site Frankfurt/M.
Germany Novo Nordisk Investigational Site Giessen
Germany Novo Nordisk Investigational Site Hannover
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Vicenza
Japan Novo Nordisk Investigational Site Kashihara-shi, Nara
Japan Novo Nordisk Investigational Site Nagoya-shi, Aichi
Japan Novo Nordisk Investigational Site Shinjuku-ku, Tokyo
Switzerland Novo Nordisk Investigational Site Zürich
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Manchester
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Japan,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (1)

Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J T — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of adverse events (AEs) reported after administration of trial product up to four weeks after trial product administration
Secondary Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample) from 0 to 168 hours after trial product administration
Secondary Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments up to four weeks after trial product administration
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