Status:
COMPLETED
Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402
Lead Sponsor:
ThromboGenics
Collaborating Sponsors:
BioInvent International AB
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00612417
Start Date
January 1 2008
End Date
June 1 2008
Last Update
April 7 2014
Active Locations (1)
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1
Cyncron CRU
Copenhagen, Denmark, DK-2100