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 (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00612417
First received: January 28, 2008
Last updated: April 4, 2014
Last verified: April 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: ThromboGenics
ClinicalTrials.gov Identifier: NCT00612417     History of Changes
Other Study ID Numbers: TB-402-002
Study First Received: January 28, 2008
Last Updated: April 4, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by ThromboGenics:
Interaction with recombinant FVIII

ClinicalTrials.gov processed this record on October 19, 2014