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

Primary Purpose

Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
catridecacog
recombinant factor XIII
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Trial part 1

Trial part 2

Arm Description

Outcomes

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

Secondary Outcome Measures

Number of adverse events (serious and non-serious)

Full Information

First Posted
March 5, 2010
Last Updated
September 20, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01082406
Brief Title
Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial part 1
Arm Type
Experimental
Arm Title
Trial part 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
catridecacog
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
recombinant factor XIII
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of adverse events (serious and non-serious)
Time Frame
over 8 weeks of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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