Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers
NCT ID: NCT01848002
Last Updated: 2013-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2003-05-31
2003-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rFXIII
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
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Berkshire, , United Kingdom
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F13-1662
Identifier Type: -
Identifier Source: org_study_id