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Trial record 11 of 1596 for:    Blood Coagulation Disorders: Clinical Trials

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082406
First Posted: March 8, 2010
Last Update Posted: September 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082406


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01082406     History of Changes
Other Study ID Numbers: NN1841-3788
2009-016438-28 ( EudraCT Number )
U1111-1113-2008 ( Other Identifier: WHO )
First Submitted: March 5, 2010
First Posted: March 8, 2010
Last Update Posted: September 21, 2016
Last Verified: September 2016

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