Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
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|ClinicalTrials.gov Identifier: NCT00859547|
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : December 8, 2011
Last Update Posted : January 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Blood Loss, Surgical||Biological: rThrombin, 1000 IU/mL||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
|Experimental: Recombinant thrombin (rThrombin), 1000 IU/mL||
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.
Other Name: RECOTHROM
- 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 population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8-10^9/L. Neutrophils: Grade 0=normal; Grade 1=<LLN-1.5x10^9/L; Grade 2=<1.5-1.0x10^9/L
- Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels [ Time Frame: Baseline and Day 29 from Baseline ]LLN=lower level of normal. Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.
- Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels [ Time Frame: Baseline and Day 29 from Baseline ]ULN=upper level of normal. Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.
- Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher [ Time Frame: Baseline and Day 29 from Baseline ]ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.
- Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher [ Time Frame: Baseline and Day 29 from Baseline ]Grade 0=normal.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859547
|United States, Arizona|
|Arizona Burn Center|
|Phoenix, Arizona, United States, 85008|
|Principal Investigator:||Kevin Foster, MD||Arizona Burn Center|