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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- ZymoGenetics
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of newborn through 17 years at time of enrollment
- •At least 1 skin graft recipient site measuring at least 1% of total body surface area (TBSA)
- •Total initial burn wounds estimated to measure less than 40% of TBSA
- •Bleeding indicating treatment with rThrombin during the surgical procedure
- •Females of child-bearing potential must have a negative urine or serum pregnancy test within 2 days prior to study-drug treatment
- •informed consent document signed by legal representative (guardian) and approved by an institutional review board/independent ethics committee (IRB/IEC)
- •Participant has signed an IRB/IEC-approved pediatric assent document, if applicable
排除标准
- •Gestational age younger than 36 weeks at birth (for infants younger than 2 years)
- •Documented active infection at the graft recipient site (participants with resolved infections at potential graft recipient sites are not excluded)
- •Acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury
- •Currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous malignancies
- •Presence of antibodies or hypersensitivity to the study drug or any of its components, other thrombin preparations, or coagulation factors
- •Transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within 24 hours prior to study-drug treatment (packed red blood cell transfusions are allowed)
- •History of HIV infection or other immunodeficiency syndrome or is taking immunosuppressive or antirejection medications
- •Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect safety or compliance with study procedures
- •Breastfeeding or being breastfed
- •Treatment with any experimental agent within 30 days of study enrollment or treatment
结局指标
主要结局
Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline and Day 29 from Baseline
Grade 0=normal.
次要结局
- Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody(At Day 29)