Clinical trial NCT00813904: Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Official title: A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss, Surgical
Lead sponsor: ZymoGenetics
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
* Age of 18 years or older at time of consent
* Bleeding indicating treatment with rThrombin during the course of the surgical procedure
* Signed informed consent document approved by an institutional review board or independent ethics committee

Exclusion Criteria:

* Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
* Known hypersensitivity to rThrombin product or any of its components
* Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
* Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
* Treatment with any experimental agent within 30 days of study enrollment or treatment

Primary outcomes:
measure: Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29
timeFrame: At baseline and Day 29
Secondary outcomes:
measure: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation
timeFrame: Baseline through Day 29, continuously
measure: Number of Participants With AEs by Maximum Severity
timeFrame: Baseline to Day 29, continuously
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Tuscon Orthopaedic Institute
state: Arizona
Study officials:
affiliation: Lotus Clinical Research
name: Neil Singla, MD
role: PRINCIPAL_INVESTIGATOR
References: