Back to resultsSafety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
Primary Purpose
Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
catridecacog
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility Criteria
Inclusion Criteria:
- Normal platelet count and clotting parameters
- Adequate renal and hepatic function
- If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit
- If a sexually active male or a sexually active female 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
- Negative drug and 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
- Any surgical procedure in the 30 days prior to enrollment
- Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
- Receipt of treatment with any experimental agent within 30 days of study enrollment
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rFXIII
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)
Incidence of yeast antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847989
Brief Title
Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
Official Title
A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rFXIII
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
catridecacog
Intervention Description
Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Days 0-28
Secondary Outcome Measure Information:
Title
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements
Time Frame
Days 0-28
Title
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)
Time Frame
Days 0-28
Title
Incidence of yeast antibodies
Time Frame
Days 0-28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal platelet count and clotting parameters
Adequate renal and hepatic function
If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit
If a sexually active male or a sexually active female 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
Negative drug and 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
Any surgical procedure in the 30 days prior to enrollment
Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
Receipt of treatment with any experimental agent within 30 days of study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berkshire
ZIP/Postal Code
SL1 2 AD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
16270634
Citation
Visich JE, Zuckerman LA, Butine MD, Gunewardena KA, Wild R, Morton KM, Reynolds TC. Safety and pharmacokinetics of recombinant factor XIII in healthy volunteers: a randomized, placebo-controlled, double-blind, multi-dose study. Thromb Haemost. 2005 Oct;94(4):802-7. doi: 10.1160/TH05-04-0292.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
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