A Randomised, Double-blind and Placebo-controlled Study Investigating the Pharmacodynamic Effects of Administration of Recombinant Human Factor VIII in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402
Sponsor study identifier
interventional
12
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 28, 2008
Actual (reported)February 11, 2008
Actual (reported)March 2008
Actual (reported)June 2008
Actual (reported)Changes in coagulation parameters after rFVIII administration
To study end
PD of TB-402, safety of TB-402 alone and with rFVIII, PK of FVIII in rFVIII-treated subjects, changes in coagulation parameters after TB-402 administration
To study end
recombinant FVIII
Placebo
Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cyncron CRU
Copenhagen, DK-2100, Denmark
Thomas J Jensen, MD, PhD
Cyncron CRU
12 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2008
First Posted
February 11, 2008
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
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Contact the study team to confirm eligibility.
Primary Completion
March 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
April 7, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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