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

Sponsors and Collaborators:	ThromboGenics BioInvent International AB
Information provided by:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00618579

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects	Phase I

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

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

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c [ Time Frame: To study end ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	February 2008
Study Completion Date:	August 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LMWH arm - active LMWH: Experimental	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
LMWH arm - placebo: Placebo Comparator	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
Warfarin arm - active warfarin: Experimental	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
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

Eligibility

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% 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618579

Locations

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 Ltd ( Sophie Gunn )
Study ID Numbers:	TB-402-003
Study First Received:	January 28, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00618579 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by ThromboGenics:

Interaction with LMWH or warfarin

Study placed in the following topic categories:

Anticoagulants
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Healthy
Warfarin
Cardiovascular Agents
Factor VIII

Calcium heparin
Body Weight
Antibodies
Fibrin Modulating Agents
Heparin
Immunoglobulins

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Heparin, Low-Molecular-Weight

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Warfarin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009