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Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01848002
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Congenital FXIII Deficiency Healthy Drug: catridecacog Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multi-dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers
Study Start Date : May 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

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Arm Intervention/treatment
Experimental: rFXIII 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 Comparator: Placebo Drug: 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).




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Days 0-33 ]

Secondary Outcome Measures :
  1. Incidence of clinically significant changes from baseline in physical examination or laboratory measurements [ Time Frame: From days -1 through day 33 ]
  2. Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay) [ Time Frame: From days -1 through day 33 ]
  3. Incidence of yeast antibodies [ Time Frame: From days -1 through day 33 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848002


Locations
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United Kingdom
Berkshire, United Kingdom, SL1 2 AD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01848002     History of Changes
Other Study ID Numbers: F13-1662
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders