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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: March 5, 2010
Last updated: May 11, 2016
Last verified: May 2016
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
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.


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

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
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Please refer to this study by its identifier: NCT01082406

United Kingdom
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S 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: May 11, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases processed this record on May 26, 2016