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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01848002
Other study ID # F13-1662
Secondary ID
Status Completed
Phase Phase 1
First received May 2, 2013
Last updated November 25, 2013
Start date May 2003
Est. completion date August 2003

Study information

Verified date November 2013
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2003
Est. primary completion date August 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Normal platelet count and clotting parameters

- Adequate renal and hepatic function

- Negative serum pregnancy test within 21 days prior to enrollment and negative urine pregnancy test on admission to the clinical research unit (if subject female and of child-bearing potential)

- Agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits (if subject a sexually active male or female of childbearing potential)

- Negative drug and negative alcohol screens

Exclusion Criteria:

- Known antibodies or hypersensitivity to FXIII

- Known bleeding or hematologic disorder

- Known allergy to yeast

- Receipt of blood products within 30 days of screening

- Donation of blood within 30 days prior to enrollment

- Surgical procedure of any type within 30 days prior to enrollment

- History of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus

- Treatment with any experimental agent within 30 days of study enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
catridecacog
For 5 consecutive days, one daily dose of rFXIII was administered intravenously (IV) to eight subjects in each dose group (10 or 25 U/kg).
placebo
For 5 consecutive days, one daily dose of placebo was administered intravenously (IV) to two subjects in each dose group (10 or 25 U/kg).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Days 0-33 No
Secondary Incidence of clinically significant changes from baseline in physical examination or laboratory measurements From days -1 through day 33 No
Secondary Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay) From days -1 through day 33 No
Secondary Incidence of yeast antibodies From days -1 through day 33 No
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