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Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402

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ClinicalTrials.gov Identifier: NCT00612417
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
BioInvent International AB
Information provided by (Responsible Party):
ThromboGenics

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
recombinant FVIII
Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
Placebo Comparator: 2
Placebo
Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402



Primary Outcome Measures :
  1. Changes in coagulation parameters after rFVIII administration [ Time Frame: To study end ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: To study end ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria include:

  • Males 18 to 45 years of age
  • Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion Criteria include:

  • Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
  • History of important bleeding episodes
  • Previous allergic reaction to immunoglobulin
  • Present or previous history of severe allergy, for example asthma or anaphylactic reactions
  • FVIII:C <50% or >150% at screening
  • Clinically significant out of range values for any coagulation test during screening
  • Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612417


Locations
Denmark
Cyncron CRU
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
ThromboGenics
BioInvent International AB
Investigators
Principal Investigator: Thomas J Jensen, MD, PhD Cyncron CRU

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00612417     History of Changes
Other Study ID Numbers: TB-402-002
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Keywords provided by ThromboGenics:
Interaction with recombinant FVIII

Additional relevant MeSH terms:
Factor VIII
Coagulants