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Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery

NCT00793234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2014-04-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of a single administration of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.

Conditions

  • Total Knee Replacement Surgery

Interventions

DRUG

TB-402

TB-402 administered as single bolus 18-24 post total knee replacement surgery.

DRUG

Enoxaparin

Enoxaparin 40mg/day sc injection for at least 10 days post-surgery

Sponsors & Collaborators

  • BioInvent International AB

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • ThromboGenics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-01-31
Completion
2010-03-31

Countries

  • Bulgaria
  • Israel
  • Latvia
  • Poland
  • Romania
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793234 on ClinicalTrials.gov