A Randomized, Double-Blind, Placebo-Controlled Dosing, Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Immuron Ltd.
- 主要终点
- Safety outcome
研究概览
简要总结
This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection, multiple dose administration study comprising three groups, with up to 40 patients in each active treatment and placebo group. Patients with biopsy proven nonalcoholic steatohepatitis (NASH) and elevated liver enzymes will be randomized to undergo a liver MRI scan and to receive Imm 124-E or placebo for 24 weeks. During this period, patients will be followed for clinical and laboratory effects. At the end of 24 weeks of treatment, patients will undergo a second liver MRI scan. Patients will be followed for an additional 4 weeks for safety after completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 18 to 75 years (inclusive)
- •Subjects with biopsy proven NASH (NAS ≥ 4) within one year prior to screening
- •Elevated liver enzymes at screening and at least once within past 6 months (ALT > 30 women, ALT > 40 men)
- •Normal or only slightly impaired synthetic liver function (serum albumin >3.5gm%, INR 0.8-1.5)
- •BMI 18 to 40 (inclusive)
- •Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study
- •Women of child bearing potential must be using adequate contraception
排除标准
- •Cow milk allergy or lactose intolerance
- •Excessive alcohol use (Women > 20 grams/day, Men > 40 grams/day).
- •Current treatment with Insulin or Incretins
- •Decompensated liver disease
- •Other or concomitant cause of liver disease (viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease)
- •Subjects who known to be HIV positive
- •Subjects who have undergone surgery within the last 3 months
- •Subjects who have had a prior gastrointestinal surgery
- •Subjects who have a history of Inflammatory Bowel Disease
- •Subjects who are receiving an elemental diet or parenteral nutrition
- •Subjects with an infectious, immune-mediated or active malignant disease (during the last 3 months)
- •Subjects with known clinically significant systemic disease
- •Subjects treated with other anti-NASH therapy(s) - thiazolidinediones, vitamin E, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies and probiotics) - within 3 months of the liver biopsy
- •Subjects who have been treated with any type of immune modulatory drug, including systemic steroids or NSAIDs, within the last 3 months
- •Subjects who have received either Immuron, 6-MP, Methotrexate, Cyclosporine, anti-TNF alpha therapies (Infliximab, Adalimumab, Etanercept) or anti-integrin therapies (namixilab) within the past 12 months
- •Known history of drug or alcohol abuse, including positive urinary drugs of abuse screen at the screening visit
- •Subjects who are pregnant as confirmed on screening test
- •Any acute medical situation (e.g. acute infection) within 48 hours of study start that is considered of significance by the Principal Investigator
研究组 & 干预措施
IMM 124-E high dose
IMM 124-E 3600 mg per day
干预措施: IMM 124-E (Biological)
IMM 124-E low dose
IMM 124-E 1800 mg per day
干预措施: IMM 124-E (Biological)
Placebo
Placebo tablets
干预措施: Placebo (Biological)
结局指标
主要结局
Safety outcome
时间窗: 28 weeks
No unexpected treatment related SAEs throughout the participation period and the follow up period
次要结局
- MRI liver fat quantitation(Baseline and 24 weeks)
- ALT levels(Baseline and 24 weeks)
- Liver enzyme improvement(Baseline and 24 weeks)
- Lipid profile(Baseline and 24 weeks)
- HbA1c(Baseline and 24 weeks)