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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy
• Interventions: Drug: recombinant factor XIII; Drug: catridecacog

• Registration Number: NCT01082406
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trial part 2	recombinant factor XIII	-
Trial part 1	catridecacog	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of adverse events (serious and non-serious)	over 8 weeks of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Harrow, United Kingdom