IRCT20200128046294N1尚未招募3 期
A Prospective Randomized Controlled Trial Comparing Three Advanced Therapies in the Treatment of Non-Alcoholic Steatohepatitis
Dr. Abidi Pharmaceuticals0 个研究点目标入组 105 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
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
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •Is a candidate for general anesthesia
- •Is eligible for bariatric surgery (SG)
- •Is =18 and =65 years old
- •Have a BMI =30 and =45 kg/m2
- •Have a platelet count >150,000 and International Normalized Ratio (INR) =1.2
- •Have appropriate composite entry criteria on liver biopsy: NAFLD with activity score between 4 and 8, presence of hepatocyte ballooning, and fibrosis stage between 1 and 3, confirmed by independent reviews by 3 liver pathologists. In case of any discrepancies in histopathologic report, a joint review by 3 study pathologists will be performed.
- •Have the ability and willingness to participate in the study and agree to any of the arms involved in the study.
- •Able to understand the options and to comply with the requirements of each arm.
- •Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential.
- •Women, of childbearing age, must agree to use reliable method of contraception for 1 year.
- •11.Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication for at least 3 months prior to entry, with HbA1c =8.5%.
- •ALT & AST > 35 in female and 45 in male
排除标准
- •1.Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic): a.Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg), b.Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA, c.Autoimmune liver disease as diagnosed by antibodies and compatible liver histology, d.Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts), e.Primary sclerosing cholangitis, f.Wilson’s disease as diagnosed by low ceruloplasmin and compatible liver histology, g.Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level and liver histology, h.Hemochromatosis as diagnosed by presence of 3+ or 4+ stainable iron on liver biopsy, i.Drug-induced liver disease as diagnosed by medical history, j.Known bile duct obstruction, k.Suspected or proven liver cancer
- •Type 1 diabetes or autoimmune diabetes
- •Known cases of human immunodeficiency virus infection
- •Prior bariatric surgery of any kind
- •Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, splenectomy, biliary diversion, and trauma
- •Thoracic, abdominal, pelvic and/or obstetric-gynecologic surgery within 6 months
- •Any other surgery requiring general anesthesia within 6 weeks prior to signing the consent
- •American Society of Anesthesiologists Class IV or V
- •History of solid organ transplant
- •Severe pulmonary disease defined as FEV1 < 50% of predicted value
- •Cardiovascular conditions including significant known coronary artery disease, dysrhythmia, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension (defined as medically treated with the mean of 3 separate measurements systolic blood pressure > 180 mm Hg or diastolic blood pressure> 110 mm Hg)
- •Chronic renal insufficiency with a eGFR is below 45 mL/min/1.73 m2, or being on dialysis
- •Presence of moderate to severe GERD (Los Angeles classification B-D)
- •Presence of moderate to large hiatal hernia (>3 cm)
- •Presence of inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
- •Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, active alcohol or substance abuse within the previous 12 months
- •Breastfeeding
- •Diagnosis of malignancy within three years (except squamous cell and basal cell cancer of the skin)
- •Anemia defined as hemoglobin less than 9 g/dL
- •Any medical condition requiring anticoagulation therapy that cannot be temporarily discontinued for surgical procedure
- •Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis
- •Use of any medications (prescription or over the counter), including herbal or other supplements for treatment of obesity or liver conditions (e.g. vitamin E or pioglitazone) during the last 3 months
- •Use of investigational therapy or participation in any other clinical trial within 3 months prior to signing the consent
- •History of pancreatitis (acute or chronic) or pancreatic carcinoma
- •History of thyroid cancer
- •Presence of concerning thyroid nodule
- •Family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •Liver biopsies < 5 mm in length
- •Absence of hepatocyte ballooning on liver biopsy
- •Absence of fibrosis on liver biopsy
- •NAFLD Activity
研究者
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