Expired Study
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Tuscon, Arizona 85712


Purpose:

The objective of this study is to assess the immunogenicity and safety of rThrombin in patients who had a prior exposure to rThrombin.


Study summary:

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 currently exist with regard to rThrombin re-exposure. This study will assess the immunogenicity and safety of rThrombin in subjects who previously received rThrombin in Phase 3 clinical trials (Protocols 499E01, 499F04) or during prior spine, AV graft formation, or PAB surgical procedures where commercial rThrombin use was documented, who are undergoing a surgical procedure during which topical rThrombin application is planned. The cohort of subjects previously exposed to rThrombin in these studies represents a unique opportunity to evaluate both the immunogenicity and safety of re-exposure to rThrombin, should some of these subjects require repeat surgery.


Criteria:

Inclusion Criteria: - Enrolled in ZymoGenetics-sponsored Phase 3 study and received treatment with rThrombin during that study or received documented treatment with commercially-available rThrombin in a prior spine, AV graft formation, or PAB surgical procedure - Age greater than or equal to 18 years at time of consent - Has bleeding for which treatment with rThrombin is indicated during the course of the surgical procedure - Has signed an informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC) Exclusion Criteria: - Is undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch - Has known hypersensitivity to the rThrombin product or any of its components - Is undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned - Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact subject safety or compliance with study procedures - Was treated with any experimental agent within 30 days of study enrollment or treatment


NCT ID:

NCT00813904


Primary Contact:

Principal Investigator
Neil Singla, MD
Lotus Clinical Research


Backup Contact:

N/A


Location Contact:

Tuscon, Arizona 85712
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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