A Prospective, Multi-centre, Double-blind, Randomized Trialof Saroglitazar 4 mg versus Placebo in Patients WithAlcoholic Liver Disease.
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- 1)Change in the following grades of FibroMax Test at 12 and 24 weeks [Timeframe:
研究概览
简要总结
Alcoholic liver disease (ALD) comprises a clinical-histologic spectrum including fatty liver,
alcoholic hepatitis (AH), and cirrhosis with its complications. This condition develops in persons
with a history of prolonged and heavy alcohol use. A number of therapies have been assessed for the
treatment of ALD, but only two drugs (Prednisolone and Pentoxifylline) have been incorporated into
the treatment guidelines published by the American Association for the Study of Liver Disease and
the European Association for the Study of the Liver. Thus, there is a need to develop a treatment
which will provide effective therapy to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Heavy alcohol consumption (defined as >20 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).
- •Should meet the following criteria in the FibroMax test: 2a) Fibro Test (for hepatic fibrosis): Grades F1, F2 and F
- •2b) Steato Test (for hepatic steatosis): Grades S1 and S
- •2c) Ash Test (for alcoholic steatohepatitis): Grades H1 and H
- •Ability to understand and give informed consent for participation.
排除标准
- •Patients with severe alcoholic liver disease as determined by the following criteria: a) Maddrey discriminant function (DF) score more than
- •b) Model for end stage liver disease (MELD) score ≥14 2)Will be excluded if the patient meets the following criteria in the FibroMax test.
- •2a) Fibro Test (for hepatic fibrosis):Grades F0 and F
- •2b) Steato Test (for hepatic steatosis): Grades S0 and S
- •2c) Ash Test (for alcoholic steatohepatitis): Grades H0 and H
- •Severe renal impairment (Estimated glomerular filtration rate below 60 ml/min per 1.73m2).
- •Uncontrolled upper gastrointestinal tract bleeding.
- •AST and ALT values more than 400 IU/L.
- •Participants on hepatotoxic medications like antitubercular medication, antiviral medication, etc.
- •Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days prior to screening.
结局指标
主要结局
1)Change in the following grades of FibroMax Test at 12 and 24 weeks [Timeframe:
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
baseline, 12 and 24 weeks].
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
a) Fibro Test (for hepatic fibrosis).
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
c) Ash Test (for alcoholic steatohepatitis).
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
b) Steato Test (for hepatic steatosis).
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
3. Change in Maddrey Discriminant function (DF) at 6, 12 and 24 weeks.
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
5. Change in AST levels at 6, 12 and 24 weeks.
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
6. Change in ALT levels at 6, 12 and 24 weeks.
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
2. Change in MELD score at 6, 12 and 24 weeks.
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
4. Change in GGT levels at 6, 12 and 24 weeks.
时间窗: 1)Timeframe:baseline, 12 and 24 weeks | 2. at 6, 12 and 24 weeks. | 3. at 6, 12 and 24 weeks. | 4. at 6, 12 and 24 weeks. | 5. at 6, 12 and 24 weeks. | 6. at 6, 12 and 24 weeks.
次要结局
- Frequency and severity of AEs and serious AEs.(2. Alteration in laboratory parameters.)