JPRN-jRCT2071210112进行中（未招募）2 期
A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Kamiya Makoto0 个研究点目标入组 440 人开始时间: 2022年1月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
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
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Liver biopsy consistent with cirrhosis (F4) due to NASH in the opinion of the central reader.
- •- Screening laboratory parameters as determined by the study central laboratory:
- •- Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m2, as calculated by the Modification of Diet in Renal Disease (MDRD)equation
- •- HbA1c <= 10%
- •- INR <= 1.4, unless due to therapeutic anticoagulation
- •- Platelet count>= 125,000/uL
- •- Alanine Aminotransferase (ALT) < 5 x ULN
- •- Serum albumin >= 3.5 g/dL
- •- Serum Alkaline Phosphatase (ALP) <= 2 x ULN
- •- BMI >= 23 kg/ m2 at screening
排除标准
- •- Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal bleeding
- •- Child-Pugh (CP) score > 6 at screening, unless due to an alternative etiology such as Gilberts syndrome or therapeutic anticoagulation
- •- Model for End-stage Liver Disease (MELD) score > 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation
- •- Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
- •- Chronic HBV infection (HBsAg positive), or Chronic HCV infection (HCV antibody and HCV RNA positive). Participants cured of HCV infection less than 2 years prior to the screening visit are not eligible
- •- History of liver transplantation
- •- Current or prior history of hepatocellular carcinoma (HCC)
- •- Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol (one unit is equivalent to 12 oz/360 mL of beer, a 4 oz/120 mL glass of wine, or 1 oz/30 mL of hard liquor).
- •- For individuals on vitamin E regimen >= 800 IU/day, or pioglitazone, dose must be stable, in the opinion of the investigator for at least 180 days prior to the historical or screening liver biopsy
- •- For individuals on medications for diabetes, dose must be stable, in the opinion of the investigator, for at least 90 days prior to the historical or screening liver biopsy
- •- History of type 1 diabetes
- •- Treatment with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the period from 90 days prior to the screening visit and for individuals with a qualifying historical liver biopsy, for 90 days prior to the date of the historical liver biopsy
- •- For participants who have not completed a series of an authorized COVID-19 vaccination regimen prior to screening, a positive result for COVID-19 on SARS-CoV-2 RT-PCR test
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