NCT00859547

Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants

A Phase 4, Open-Label, Single-Group Safety and Immunogenicity Study of RECOTHROM® (rThrombin) in Pediatric Subjects Undergoing Synchronous Burn Wound Excision and Skin Grafting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ZymoGenetics · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.

Detailed description

The safety, immunogenicity, and efficacy of rThrombin have been evaluated in 5 Phase 2 studies, 1 pivotal Phase 3 study, and 1 Phase 3b study, in surgical indications such as: spinal surgery, major hepatic resection, peripheral arterial bypass surgery, arteriovenous graft formation for hemodialysis access, and burn wound excision. Limited data currently exist on the effects of rThrombin exposure in pediatric patients. This Phase 4 trial aims to provide additional information on the use of rThrombin in children by evaluating the drug's safety and immunogenicity when administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric burn patients.

Conditions

• Blood Loss, Surgical

Interventions

Type	Name	Description
BIOLOGICAL	rThrombin, 1000 IU/mL	rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-03-11
• Last updated: 2012-01-26
• Results posted: 2011-12-08

Locations

1 site across 1 country: United States