A Randomised, Controlled Study Investigating the Safety and Anticoagulant Activity of Administration of Low-molecular-weight Heparin in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402 and the Safety and Anticoagulant Activity of Administration of TB-402 in Healthy Male Subjects Treated With Warfarin
Sponsor study identifier
interventional
15
1 country
1
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 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 28, 2008
Actual (reported)February 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 20, 2008
Actual (reported)June 2008
Actual (reported)August 2008
Actual (reported)Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c
To study end
Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm)
To study end
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cyncron CRU
Copenhagen, Denmark
Thomas J Jensen, MD, PhD
Cyncron CRU
15 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2008
First Posted
February 20, 2008
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers
Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers
Contact the study team to confirm eligibility.
Primary Completion
June 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
April 7, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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