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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618579

Enrollment

Registered

2008-02-20

Start date

2008-02-29

Completion date

2008-08-31

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Interaction with LMWH or warfarin

Brief summary

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

Interventions

DRUGLWMH 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026