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Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

NCT01344954 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2012-08-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.

Conditions

  • Prophylaxis of Venous Thromboembolic Events

Interventions

DRUG

TB-402

Administered intravenously over 10 minutes

DRUG

Rivaroxaban

Administered orally as a capsule once a day for 35 days

DRUG

TB-402

Administered intravenously over 10 minutes

Sponsors & Collaborators

  • BioInvent International AB

    collaborator INDUSTRY

  • ThromboGenics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-12-31
Completion
2012-05-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Hungary
  • Latvia
  • Netherlands
  • Poland
  • 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 NCT01344954 on ClinicalTrials.gov