Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

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

Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
      • Frankfurt/M., Germany, 60590
        • Novo Nordisk Investigational Site
  • Latvia
      • Riga, Latvia, 1006
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years
  • Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
  • Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)

Exclusion Criteria:

  • Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
  • History of FVIII inhibitors
  • Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
  • Known or suspected allergy to trial product (FVIII) or related products
  • Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
  • Body mass index (BMI) above 30 kg/m^2

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lot A
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Experimental: Lot B
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Experimental: Lot C
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Experimental: Lot D
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Drug: turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Drug: turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Area under the FVIII activity-time curve (AUC)
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Terminal half-life of FVIII (t½)
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Clearance of FVIII (CL)
Time Frame: up to 48 hours after i.v. administration
up to 48 hours after i.v. administration
Incidence of adverse events (AEs) including FVIII inhibitors
Time Frame: After approximately 3 months (at end of trial)
After approximately 3 months (at end of trial)

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

December 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 26, 2012

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

  • NN7008-4015
  • 2012-001444-21 (EudraCT Number)
  • U1111-1129-1517 (Other Identifier: WHO)

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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