ARIXTRA Local Study For Registration In China.

Thromboembolism Clinical Trial

Official title:

Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328939
• Other study ID #: ITI105316
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2006
• Last updated: May 31, 2012
• Start date: May 2004

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Patients undergoing either an elective major hip or knee replacement or revision.

• Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.

Exclusion criteria:

• History of serious active bleeding in last 3 month

• Concurrent or history of thrombocytopenia ( Platelet< 100x109/L)

• History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product

• Acute bacterial endocarditis

• Congenital or acquired bleeding disease in last 3 months

• Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia

• Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye

• Conditions need to leave a tubule in intradural or extradural

• Contraindication to anticoagulant or condition required to take long term oral anticoagulant

• Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb

• Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days.

• Concurrently to have hip and knee or double hip/knee replacement at the same time

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hip Replacement
• Knee Replacement
• Thromboembolism

Intervention

Drug:
• ARIXTRA infusion

• Enoxaparine infusion

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Chengdu	Sichuan
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Qingdao	Shandong
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Xi'an	Shaanxi
China	GSK Investigational Site	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary	Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.