- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00056589
Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency
January 10, 2017 updated by: Novo Nordisk A/S
A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency
This trial was conducted in the United States of America (USA).
The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Los Angeles, California, United States, 90027
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documental congenital FXIII deficiency
- Normal platelet count and clotting parameters
- Adequate renal and hepatic function
- If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
- 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:
- Received blood products or FXIII concentrates within 4 weeks of study enrollment
- Known antibodies to FXIII
- Hereditary or acquired coagulation disorder other than FXIII deficiency
- Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
- Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
- Received treatment with any experimental agent within 30 days of study enrollment
- Any surgical procedure in the 30 days prior to enrollment
- Donated blood within 30 days prior to enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rFXIII
|
Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: Days 0-28
|
Days 0-28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements
Time Frame: Days 0-28
|
Days 0-28
|
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)
Time Frame: Days 0-28
|
Days 0-28
|
Incidence of yeast antibodies
Time Frame: Days 0-28
|
Days 0-28
|
FXIII activity measured by the Berichrom® assay
Time Frame: Days 0-28
|
Days 0-28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
October 1, 2003
Study Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
March 18, 2003
First Submitted That Met QC Criteria
March 19, 2003
First Posted (Estimate)
March 20, 2003
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F13-1663
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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