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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Congenital FXIII Deficiency; Congenital Bleeding Disorder

Treatments: Drug: recombinant factor XIII; Drug: catridecacog

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082406

2009-016438-28 (EudraCT Number)

NN1841-3788

U1111-1113-2008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Trial part 1

Experimental group

Treatment:

Drug: catridecacog

Trial part 2

Experimental group

Treatment:

Drug: recombinant factor XIII