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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612417
• Other study ID #: TB-402-002
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2008
• Last updated: April 4, 2014
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Denmark	Cyncron CRU	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
ThromboGenics	BioInvent International AB

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in coagulation parameters after rFVIII administration		To study end	No
Secondary	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		To study end	Yes