CTRI/2010/091/000108已完成2 期
A prospective, multi-centric, open-label, single arm study to evaluate the safety and efficacy of 4mg of ZYH1 in Non-alcoholic steatohepatitis (NASH). - NA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subject has given informed consent for participation in this trial
- •Biopsy proven NASH (Biopsy done in last one year).
- •ALT > than 1.5 times upper normal limit.
- •Patient presently on lifestyle modification for NASH for at least one month.
- •BMI between 23 to 40 kg/m2
- •Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
- •o Hemoglobin > 9 gm/dL
- •o White blood cell (WBC) > 2.5 K/UL
- •o Neutrophil count > 1.5 K/UL
- •o Platelets > 100 K/UL
- •o Serum bilirubin, <1.5mg%
- •o Albumin > 3.2 g/dL
- •o Serum creatinine within normal limits
排除标准
- •Pregnancy and lactation
- •Subjects with history of gall stone
- •Subjects with history of myopathies or evidence of active muscle diseases
- •Subject with history of alcohol consumption > than 20 gm/week and/or drug abuse
- •Known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
- •Participation in any other clinical trial in past 3 months
- •History of malignancy; active neoplasm.
- •Previous liver biopsy that demonstrated presence of cirrhosis or radiologic imaging consistent with cirrhosis or portal hypertension
- •Type 2 diabetes treated with agents other than the secretagogues (these include, insulin thiazolidinediones, alpha-glucosidase inhibitors, exenatide, pramlintide). Metformin will be allowed provided dose is stable science last 6 months.
- •Evidence of poorly-controlled diabetes [glycosylated hemoglobin (HbA1c) > 9%].
- •Type I diabetes mellitus.
- •Abnormal PT/INR (Prothrombin Time/International normalized ratio)
- •Patient on fibrates (Other antidyslipedemic drugs will be allowed provided dose is stable in last 6 months)
- •Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or NASH for more than 12 consecutive weeks in the 1 year prior to start of the study; (these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens, valproate/valproic acid, chloroquine, anti-HIV drugs etc.)
- •History of thyroid disease poorly controlled on prescribed medications
- •History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease, including myocardial infarction, except patients with only well controlled hypertension.
- •History of bariatric surgery, or undergoing evaluation for bariatric surgery.
- •History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption)
- •Subject on any treatment with other drugs claimed for treatment of NASH (Pentoxyphyllin, Ursodeoxycholic acid, acetyl cholinesterase enzyme (ACE) inhibitors antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas).) or any medicine in clinical trials for NASH.
- •Other cause of chronic liver disease [autoimmune,primary biliary cirrhosis, hepatitis B virus (HBV), Wilson, alpha-1-antitrypsin deficit, hemochromatosis etc] i.e. Antinuclear antibodies (ANA) > 1:160, Anti-smooth muscle Ab positive >1:160 , Serum hepatitis B surface antigen (HepBsAg) positive, Serum hepatitis C antibody (HepC Ab) positive, transferrin saturation > 45%
研究者
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