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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary: 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.
Sponsor: ZymoGenetics

Current Primary Outcome:

  • Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity [ Time Frame: Days 1 through 29, continuously ]
    An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment
  • Number of Participants With AEs by Maximum Severity [ Time Frame: Days 1 through 29, continuously ]
    An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.
  • Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts [ Time Frame: Baseline and Day 29 from Baseline ]
    Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical

    Original Primary Outcome: Adverse events, including standard clinical laboratory abnormalities [ Time Frame: Through Day 29 ]

    Current Secondary Outcome: Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody [ Time Frame: At Day 29 ]

    Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.


    Original Secondary Outcome: Incidence of anti-rThrombin product antibody development [ Time Frame: Day 29 ]

    Information By: ZymoGenetics

    Dates:
    Date Received: March 9, 2009
    Date Started: March 2009
    Date Completion:
    Last Updated: January 25, 2012
    Last Verified: January 2012