Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01082406
First received: March 5, 2010
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.


Condition Intervention Phase
Congenital Bleeding Disorder
Congenital FXIII Deficiency
Healthy
Drug: catridecacog
Drug: recombinant factor XIII
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events (serious and non-serious) [ Time Frame: over 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trial part 1 Drug: catridecacog
Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.
Experimental: Trial part 2 Drug: recombinant factor XIII
Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 18.5 and 30 kg/m2
  • Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician
  • Non-smokers

Exclusion Criteria:

  • Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician
  • Blood transfusion within 3 months of trial start
  • Positive for hepatitis B or C infection
  • Positive for Human Immunodeficiency Virus (HIV) infection
  • Excessive consumption of a diet deviating from a normal diet as judged by the physician
  • Blood or plasma donation within the last 3 months prior to trial start
  • Subjects with any history of migraine
  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: NCT01082406

Locations
United Kingdom
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Flemming Møller, MSc, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01082406     History of Changes
Other Study ID Numbers: NN1841-3788, 2009-016438-28, U1111-1113-2008
Study First Received: March 5, 2010
Last Updated: June 10, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on September 18, 2014