Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects
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)
3 other identifiers
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 5, 2010
CompletedFirst Posted
Study publicly available on registry
March 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedSeptember 21, 2016
September 1, 2016
4 months
March 5, 2010
September 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay
after 4 weeks of treatment
Secondary Outcomes (1)
Number of adverse events (serious and non-serious)
over 8 weeks of treatment
Study Arms (2)
Trial part 1
EXPERIMENTALTrial part 2
EXPERIMENTALInterventions
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Harrow, HA1 3UJ, United Kingdom
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2010
First Posted
March 8, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 21, 2016
Record last verified: 2016-09