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NCT01205724 Clinical Trial

Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

Congenital Bleeding Disorder Clinical Trial

— pathfinder™1  

Official title:
A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A

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

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
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Completed NCT02568202 - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) N/A
Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT02490787 - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Phase 1
Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A
Completed NCT01230021 - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency Phase 3

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