Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A (pathfinder™1)

February 9, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt/M., Germany, 60590
        • Novo Nordisk Investigational Site
      • Giessen, Germany, 35392
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30625
        • Novo Nordisk Investigational Site
  • Italy
      • Firenze, Italy, 50134
        • Novo Nordisk Investigational Site
      • Vicenza, Italy, 36100
        • Novo Nordisk Investigational Site
  • Japan
      • Kashihara-shi, Nara, Japan, 634 8522
        • Novo Nordisk Investigational Site
      • Nagoya-shi, Aichi, Japan, 466 8560
        • Novo Nordisk Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 160 0023
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • Turkey
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE1 7EH
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • Novo Nordisk Investigational Site
  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: turoctocog alfa pegol
Single dose (low) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Drug: turoctocog alfa pegol
Single dose (medium) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Drug: turoctocog alfa pegol
Single dose (high) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Experimental: B
Drug: turoctocog alfa pegol
Single dose (low) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Drug: turoctocog alfa pegol
Single dose (medium) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Drug: turoctocog alfa pegol
Single dose (high) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Experimental: C
Drug: turoctocog alfa pegol
Single dose (low) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Drug: turoctocog alfa pegol
Single dose (medium) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003
Drug: turoctocog alfa pegol
Single dose (high) administered intravenously (into the vein)
Other Names:
  • NNC 0129-0000-1003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of adverse events (AEs) reported after administration of trial product
Time Frame: up to four weeks after trial product administration
up to four weeks after trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample)
Time Frame: from 0 to 168 hours after trial product administration
from 0 to 168 hours after trial product administration
Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments
Time Frame: up to four weeks after trial product administration
up to four weeks after trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimate)

September 20, 2010

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7088-3776
  • 2010-018520-68 (EudraCT Number)
  • U1111-1116-2043 (Other Identifier: WHO)
  • JapicCTI-101293 (Other Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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