Official Title: “A Randomised, Controlled Study Investigating the Safety and Anticoagulant Activity of Administration of Low-Molecular-Weight Heparin in Healthy Male Subjects Treated With the Monoclonal Anti-Factor VIII Antibody, TB-402 and the Safety and Anticoagulant Activity of Administration of TB-402 in Healthy Male Subjects Treated With Warfarin”

Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
  • Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: LMWH arm - active LMWH
• Placebo Comparator: LMWH arm - placebo
• Experimental: Warfarin arm - active warfarin
• Other: Warfarin arm - control

Primary Measures

• Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c
  • Time Frame: To study end
    Safety Issue?: No

Secondary Measures

• Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm)
  • Time Frame: To study end
    Safety Issue?: Yes

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% 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: ThromboGenics

Overall Clinical Trial Officials and Contacts

Thomas J Jensen, MD, PhD Principal Investigator Cyncron CRU  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618579

Study ID Number: TB-402-003

ClinicalTrials.gov Identifier: NCT00618579

Health Authority: Denmark: Danish Medicines Agency