A Double-Blind, Placebo-Controlled Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
研究概览
简要总结
The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals ≥ 21 years with a diagnosis of acute AH. The diagnosis of acute alcoholic hepatitis will be based on clinical features and testing including hepatomegaly, jaundice, fever, leukocytosis, compatible liver biochemistries in the context of heavy alcohol consumption. A liver biopsy is not mandatory, but will be required to confirm the diagnosis if a firm diagnosis of AH cannot be made on clinical and laboratory criteria
- •Moderate severity defined as MELD score > 11 and < 20
- •Heavy alcohol consumption (defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment)
- •Written informed consent
- •Negative urine pregnancy test where appropriate
- •Women of child bearing potential should be willing to practice contraception throughout the treatment period
排除标准
- •Significant active infection (e.g., sepsis, or spontaneous bacterial peritonitis; SBP). Subjects can be reconsidered after the infection is under control.
- •Serum creatinine > 2.5 mg/dL
- •Must not be receiving systemic steroids > 1 week at the time of Screening or any experimental medicines for AH
- •Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
- •Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
10 mg Obeticholic Acid (OCA)
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.
干预措施: 10 mg Obeticholic Acid (OCA) (Drug)
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs) During the Treatment Phase
时间窗: Baseline to 6 weeks (Day 42)
Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).
MELD Score Mean(SD)
时间窗: Baseline to 6 weeks (Day 42)
The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
MELD Score Change From Baseline Mean(SD)
时间窗: Baseline to 6 weeks (Day 42)
The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
次要结局
- Any SAEs During the Follow-up Phase(Days 42 to 180)
- SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases(Baseline to 180 days)
- Change in MELD Score at 90 and 180 Days(Days 90 and 180)
- Adverse Events (AEs) During the Treatment and Follow-up Phases(Baseline to 180 days)
- Percentage of Participants Deceased at Day 42, 90 and 180(Days 42, 90 and 180)
- Rates of Hospitalization(Baseline to 180 days)
- Changes in Intestinal Inflammation(Baseline to Day 180)
- Changes in Serum Oxidative Stress.(Baseline to 180 days)
- Length of Hospital Stays(Baseline to 180 days)
- Changes in Bacterial Translocation(Baseline to 180 days)
- Changes in Cytokines(Baseline to 180 days)
- Change in Child-Pugh Score at Day 42, 90 and 180 Days(Days 42, 90 and 180)
- Changes in Activation of Innate Immunity(Baseline to 180 days)
- Discontinuation Rate During the Treatment and Follow-up Phases(Baseline to 180 days)
研究者
Naga P. Chalasani
Naga Chalasani, MD, FACG
Indiana University School of Medicine