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

This study has been completed.
Sponsor:
Collaborator:
BioInvent International AB
Information provided by:
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00612417
First received: January 28, 2008
Last updated: November 17, 2008
Last verified: September 2008
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • Changes in coagulation parameters after rFVIII administration [ Time Frame: To study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sophie Gunn, ThromboGenics Ltd
ClinicalTrials.gov Identifier: NCT00612417     History of Changes
Other Study ID Numbers: TB-402-002
Study First Received: January 28, 2008
Last Updated: November 17, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by ThromboGenics:
Interaction with recombinant FVIII

Additional relevant MeSH terms:
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013