NCT00586911已完成2 期
A Randomized, Placebo-Controlled Trial of Betaine in Patients With Nonalcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- changes in degree of steatosis, necroinflammatory activity and fibrosis in liver biopsy.
研究概览
简要总结
To assess the safety and efficacy of betaine in patients with NASH on markers of disease severity such as liver histology, liver biochemistries, and health related quality of life.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females, age 18 - 70 (inclusive) with NASH.
- •Abnormal aminotransferase levels (1.5x normal) on at least two occasions at less three months apart.
- •Histologic evidence of steatohepatitis on liver biopsy performed within six months of entry.
- •Absence of sustained alcohol ingestion (less than 20 g/d in women or 30 g/d in men).
- •Compensated liver disease and blood cell counts within the following limits: Hb > 12 gr/dl, platelets > 120,000/mm3, and WBC > 3,000/mm3
- •TSH (thyroid-stimulating hormone) within normal limits of testing laboratory.
- •Appropriate exclusion of other liver disease such as viral, autoimmune and metabolic/hereditary liver disease.
- •If a history of diabetes, a hemoglobin A1C < 10.0%.
- •Alpha-fetoprotein in normal range (obtained within the previous year), or if greater than normal, the patient requires a negative ultrasound for hepatocellular carcinoma within prior 3 months.
- •Sexually active female patients of childbearing potential must practice adequate contraception during the treatment period and for 6 months after discontinuation of therapy. A pregnancy test obtained at entry prior to the initiation of treatment must by negative. Female patients must not be breast-feeding.
- •Sexually active male patients must practice acceptable methods of contraception during the treatment period and for 6 months after discontinuation of therapy.
- •Written informed consent for participation in this study.
排除标准
- •Treatment with any experimental drug for NASH, betaine, ursodeoxycholic acid (URSO), methionine, rosiglitazone, metformin, pioglitazone, or vitamin E within 3 months of enrollment or at time of pre-entry liver biopsy. (Patients with diabetes and on stable medical management for six months prior to entry and an anticipated stable program throughout the study will be eligible. Medications that may be used include insulin, biguanides, thiazolidnediones, metformin, and sulfonylureas. Patients with hyperlipidemia on a medical program for control of lipids who have had a change in drug treatment in the preceding six months or with anticipated changes in the year of the study will also be eligible.)
- •Any cause for the liver disease based on patient history and biopsy (where applicable) other than NASH
- •Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy.
- •Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study such as significant cardiovascular dysfunction or chronic obstructive pulmonary disease requiring specific therapy
- •Pregnancy or breastfeeding.
- •Unwillingness of patient and/or partner to use contraception during treatment.
- •Previous malignant disease (other than non-melanoma skin cancer) in the previous two years.
- •Substance abuse, such as alcohol, I.V. drugs and inhaled drugs.
- •Any other conditions that in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol.
- •Lactose intolerant patient since placebo preparation contains lactose.
研究组 & 干预措施
Cystadane
Active Comparator
干预措施: Cystadane (Drug)
Identical Placebo
Placebo Comparator
干预措施: Identical Placebo (Drug)
结局指标
主要结局
changes in degree of steatosis, necroinflammatory activity and fibrosis in liver biopsy.
时间窗: 1 year
次要结局
- Secondary end-points will be changes in liver test results and health related quality of life.(1 year)
研究者
研究点 (2)
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