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Completed

NCT Number: 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

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

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Haemophilia A Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Århus N, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Ongoing participation in pathfinder™2
  • Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)

Exclusion criteria

  • FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
  • Planned surgery during the trial
  • Major surgery performed within 4 weeks prior to screening
  • Previous participation in this trial. Participation is defined as signed informed consent
  • Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol

Treatment and study plan

Turoctocog alfa pegol

Drug

Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.

Primary outcomes

  1. Area under the FVIII activity-time curve

    Time frame: From 0 to 96 hours post injection

Secondary outcomes

  1. FVIII activity 30 min post administration - dose normalised to 50 U/kg

    Time frame: From time of trial product administration to 96 hours post-dose

  2. Area under the FVIII activity-time curve from 0 to infinity

    Time frame: From time of trial product administration to 96 hours post-dose

  3. Clearance in blood plasma of FVIII activity

    Time frame: From time of trial product administration to 96 hours post-dose

  4. Incremental recovery in blood plasma of FVIII activity

    Time frame: From time of trial product administration to 96 hours post-dose

  5. Terminal half-life

    Time frame: From time of trial product administration to 96 hours post-dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A.

Acronym: pathfinder™7

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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