Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Cyncron CRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LMWH arm - active LMWH	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
Placebo Comparator: LMWH arm - placebo	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
Experimental: Warfarin arm - active warfarin	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
Other: Warfarin arm - control	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c	To study end

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	To study end

Collaborators and Investigators

• Sponsor: ThromboGenics
• Collaborators: BioInvent International AB
• Investigators: Principal Investigator: Thomas J Jensen, MD, PhD, Cyncron CRU

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: January 28, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Interaction with LMWH or warfarin
• Additional Relevant MeSH Terms: Anticoagulants; Warfarin
• Other Study ID Numbers: TB-402-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No