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Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

Blood Loss, Surgical Clinical Trial

Official title:
A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis

Clinical Trial Summary

The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.

Clinical Trial Description

The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (PAB) surgery, arteriovenous (AV) graft formation for hemodialysis access, and skin graft surgery following burn injury. Limited data on rThrombin reexposure currently exist. This study will assess the immunogenicity and safety of rThrombin in participants who are undergoing a surgical procedure during which topical rThrombin application is planned and who previously received rThrombin in Phase 3 clinical trials or during prior spine, AV graft formation, or PAB surgical procedures. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00813904
Study type Interventional
Source ZymoGenetics
Contact
Status Completed
Phase Phase 4
Start date January 2009
Completion date July 2010
View Details
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