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Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

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Contents

clinicaltrials.gov/study/NCT00491608
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT004916080
Health Conditions in Trial
‌
Vascular surgery
0
Trial Recruitment Size
2340
Trial Sponsor
ZymoGenetics
ZymoGenetics
0
Clinical Trial Start Date
2007
0
Primary Completion Date
2008
0
Study Completion Date
2008
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Interventional Trial Phase
Phase 30
Official Name
A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis0
Last Updated
January 13, 2012
0
Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
rThrombin0
Study summary

The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.

Timeline

No Timeline data yet.

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