A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
- 试验地点
- 17
- 主要终点
- Time to solid food tolerance
研究概览
简要总结
Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 15 sites. All patients will have received a Screening CECT of the abdomen/pancreas before being randomized into the study. CECTs performed as standard of care (SOC) may be used as the Screening CECT but must have been performed in the 24 hours before Consent or after Consent and before Randomization. The Start of First Infusion of Study Drug (SFISD) should occur within 8 hours of the patient or LAR providing informed consent. Patients will be randomly assigned to either Auxora at one of three dose levels i.e, 2.0 mg/kg (1.25 mL/kg), 1.0 mg/kg (0.625 mL/kg), and 0.5 mg/kg (0.3125 mL/kg), every 24 hours (±1 hour) for three consecutive days for a total of three infusions or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain in the hospital as per the standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment. It is also recommended that all patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection that would necessitate continued hospitalization. Tolerating solid food is defined as eating ≥50% of a low fat, ≥500-calorie solid meal without an increase in abdominal pain or vomiting. If the patient is not tolerating either solid or liquid meals, tube feedings should be considered.
All protocol required laboratory testing, except biomarker and pharmacokinetic (PK) samples, will be performed at the local laboratory. Results from the biomarkers and PK blood samples collected as part of the protocol and being tested at a central lab will not be available to assist the Principal Investigator (PI) or treating physician in managing the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: All of the following must be met for a patient to be randomized into the study:
- •The diagnosis of AP has been established by the presence of abdominal pain consistent with AP together with at least 1 of the following 2 criteria: a.
- •Serum lipase > 3 times the upper limit of normal (ULN); b.
- •The diagnosis of SIRS has been established by the presence of at least two of the following four criteria: a.
- •Temperature < 36°C or > 38°C; b.
- •Heart rate > 90 beats/minute; c.
- •Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg; d.
- •White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms;
- •At least one of the following criteria is also present: a.
- •A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization; b.
- •Abdominal examination documenting either abdominal guarding or rebound tenderness; c.
- •Hematocrit ≥44% for men or ≥40% for women;
- •The patient is ≥ 18 years of age;
- •Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization;
- •A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug.
- •A female patient must not attempt to become pregnant for 180 days;
- •A male patient must not donate sperm for 180 days;
- •The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.
排除标准
- •Patients with any of the following conditions or characteristics must be excluded from randomizing:
- •Expected survival <6 months;
- •Suspected presence of cholangitis in the judgment of the treating physician;
- •The patient has a known history of: a. Organ or hematologic transplant; b. HIV, hepatitis B, or hepatitis C infection; c. Chronic pancreatitis;
- •Current treatment with: a. Chemotherapy; b. Immunosuppressive medications or immunotherapy Chemotherapy.
- •â€¢ Cyclosporine, Tacrolimus, • Sirolimus, Everolimus, • Azathioprine, • Cyclosphosphamide, • Methotrexate, • Mycophenolate, • Leflunomide,• Biologics/Monoclonals: abatacept, adalimumab, alemtuzumab, anakinra, basilizimab, belimumab, bevacizumab, brodalumab, canakinumab, certolizumab, cetuximab, clazakizumab, daclizumab, eculizumab, etanercept, golimumab, infliximab, interferon, ixekizumab, muromonab, natalizumab, omalizumab, rituximab, secukinumab, tocilizumab, trastuzumab, ustekinumab, vedolizumab, • Baracitinib • Tofacitinib c. Pancreatic enzyme replacement therapy; d. Hemodialysis or Peritoneal Dialysis;
- •The patient is known to be pregnant or is nursing;
- •The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization;
- •Allergy to eggs or known hypersensitivity to any components of study drug.
结局指标
主要结局
Time to solid food tolerance
时间窗: Following the start of first Infusion (SFISD) and at each meal time
次要结局
- Solid food tolerance at 48 hours, 72 hours, and(96 hours after the SFISD and at discharge)