NCT05632861招募中2 期
Efficacy and Safety of HuHuangLianzonggan Capsule in Subjects With Nonalcoholic steatoHEPAtitis: a Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 tRial(HHL-HEPAR)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 20
- 主要终点
- Proportion of subjects with ≥ 30% relative fat reduction on MRI-PDFF at week 12.
研究概览
简要总结
This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18-75 years of age inclusive(including boundary values).
- •Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooning degeneration≥1;② fibrosis stage 1 to
- •Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
- •No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12 months.
- •Patients who are taking chronic drugs(including but not limited to antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have a steady dose for at least 3 months before liver biopsy.
- •Weight was stable(the change is no more than 5%) during the 6 months prior to Screening.
- •No attempt to change lifestyle (diet and/or exercise) during the 3 months prior to Screening.
- •Ability to understand the requirements of the study and willingness to provide written informed consent.
- •Have no pregnancy program and take effective contraceptive measures voluntarily.
- •Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment.
排除标准
- •Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids, >5 mg/day of prednisone equivalent [one short (<2 weeks) course of oral corticosteroids, more than 3 months before the liver biopsy is allowed], or oestrogens [at doses greater than those used for contraception or hormone replacement]).
- •Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, abetalipoproteinemia, lipoatrophy , Coeliac disease, Primary sclerosing cholangitis, Alpha-1-antitrypsin deficiency, Drug-induced liver disease.
- •Model for End-stage Liver Disease (MELD) score >
- •Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.
- •History of or planned liver transplant.
- •Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positive hepatitis C antibody.
- •Abnormal liver function as defined by Screening central laboratory evaluation of any of the following: ALT or AST >5 × ULN; Alkaline phosphatase (ALP) >2 × ULN; albumin below the lower limit of the normal range; total bilirubin level >1.5 × ULN (patients with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range).
- •In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence of impaired coagulation.
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value <30 mL/min/1.73 m
- •Patient currently receiving any approved treatment for NASH.
- •HbA1c ≥9% or fasting blood-glucose>13.9 mmol/L at Screening.
- •Diabetes mellitus other than type 2 (e.g. type 1, diabetes caused by drugs or chemicals, and immune-mediated diabetes).
- •Those who are underweight, of normal weight, or severely obese, i.e BMI<23 kg/m2 or BMI≥40 kg/m
- •Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifying liver biopsy.
- •Uncontrolled hypertension (values ≥160/100 mm Hg) or hypotension（values <80/50 mmHg）.
- •Acute vascular events including ACS, stroke, peripheral vascular disease worsened, or any vascular/cardiac surgery within the 6 months prior to Screening.
- •Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events.
- •Do not have a liver biopsy within the 6 months prior to Screening and refuse to take liver biopsy at Screening.
- •Allergic constitution, or allergic to the test drug or its ingredients.
- •Women who are pregnant or lactating.
- •Participate in clinical trials of other drugs within 3 months before screening.
- •The researchers did not consider it appropriate to participate in this study.
研究组 & 干预措施
Experimental group
Experimental
HuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day
干预措施: HuHuangLianzonggan capsule (Drug)
Placebo group
Placebo Comparator
HuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day
干预措施: HuHuangLianzonggan capsule placebo (Drug)
结局指标
主要结局
Proportion of subjects with ≥ 30% relative fat reduction on MRI-PDFF at week 12.
时间窗: Week 12
Change from baseline in hepatic fat fraction assessed by MRI-PDFF at week 12.
时间窗: Week 12
次要结局
- Change from baseline in Body Mass Index (BMI) at week 4, 12.(Week 4, 12)
- Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) at week 4, 12.(Week 4, 12)
- Change from baseline in High Density Lipoprotein Cholesterol (HDL-C) at week 4, 12.(Week 4, 12)
- Change from baseline in Aspartate aminotransferase (AST) at week 4, 12.(Week 4, 12)
- Change from baseline in N-terminal type Ⅲ collagen propeptide (Pro-C3) at week 4, 12.(Week 4, 12)
- Change from baseline in waist hip rate at week 4, 12.(Week 4, 12)
- Change from baseline in fasting blood glucose at week 4, 12.(Week 4, 12)
- Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR) at week 4, 12.(Week 4, 12)
- Change from baseline in total bilirubin (TBil) at week 4, 12.(Week 4, 12)
- Change from baseline in 2 hours postprandial hyperglycemia at week 4, 12.(Week 4, 12)
- Change from baseline in Total Cholestrol (TC) at week 4, 12.(Week 4, 12)
- Change from baseline in Cytokeratin18 (CK-18) at week 4, 12.(Week 4, 12)
- Change from baseline in weight at week 4, 12.(Week 4, 12)
- Change from baseline in Alanine aminotransferase (ALT) at week 4, 12.(Week 4, 12)
- Change from baseline in triglyceride (TG) at week 4, 12.(Week 4, 12)
- Change from baseline in Glycosylated hemoglobin A1c (HbA1c) at week 12.(Week 12)
- Change from baseline in Fibrosis 4 score at week 4, 12.(Week 4, 12)
- Change from baseline in Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD) at week 4, 12.(Week 4, 12)
- Change from baseline in ferritin at week 4, 12.(Week 4, 12)
研究者
研究点 (20)
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