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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01692925
First received: September 21, 2012
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: turoctocog alfa 2000 IU/vial
Drug: turoctocog alfa 3000 IU/vial
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Area under the FVIII activity-time curve (AUC) [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
  • Terminal half-life of FVIII (t½) [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
  • Clearance of FVIII (CL) [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) including FVIII inhibitors [ Time Frame: After approximately 3 months (at end of trial) ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: December 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lot A Drug: turoctocog alfa 2000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.
Experimental: Lot B Drug: turoctocog alfa 2000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.
Experimental: Lot C Drug: turoctocog alfa 2000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.
Experimental: Lot D Drug: turoctocog alfa 3000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692925

Locations
Germany
Berlin, Germany, 10249
Latvia
Riga, Latvia, 1006
Spain
Madrid, Spain, 28046
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Judi Møss Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01692925     History of Changes
Other Study ID Numbers: NN7008-4015, 2012-001444-21, U1111-1129-1517
Study First Received: September 21, 2012
Last Updated: April 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Latvia: Ministry of Health
Spain: Spanish Agency of Medicines and Health Care Products

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014