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Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

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Contents

clinicaltrials.gov/study/NCT00813904
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT008139040
Trial Recruitment Size
310
Trial Sponsor
ZymoGenetics
ZymoGenetics
0
Clinical Trial Start Date
2009
0
Primary Completion Date
2010
0
Study Completion Date
2010
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Interventional Trial Phase
Phase 40
Official Name
A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis0
Last Updated
December 8, 2011
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
rThrombin, 1000 IU/mL0
Study summary

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

Timeline

No Timeline data yet.

Further Resources

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