Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

NCT01848002 | Completed Phase 1

• 1 other identifier: F13-1662
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Days 0-33

Secondary Outcomes (3)

• Incidence of clinically significant changes from baseline in physical examination or laboratory measurements

  From days -1 through day 33

• Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)

  From days -1 through day 33

• Incidence of yeast antibodies

  From days -1 through day 33

Study Arms (2)

rFXIII

EXPERIMENTAL

Drug: catridecacog

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

catridecacog DRUG

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).

rFXIII

placebo DRUG

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).

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Berkshire, SL1 2 AD, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2003
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

GB (1)