NCT05115942已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B
Beijing Continent Pharmaceutical Co, Ltd.44 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2021年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 44
- 主要终点
- Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline.
研究概览
简要总结
This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study.
The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.
详细描述
248 patients with chronic viral hepatitis B liver fibrosis were enrolled in this 52-week study, and randomized into hydronidone or placebo group. Each group has 124 patients. Both groups were treated with entecavir antiviral basic therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years old (including 18 and 65 years old, based on the time of signing the written informed consent); gender is not limited.
- •History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6 months.
- •Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3).
- •Positive HBV DNA.
- •ALT < 8 x ULN (standard upper limit).
- •No antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment.
- •3 months before inclusion, he/she had not received any of the following proprietary Chinese medicines that may have anti-fibrosis effects: Fuzheng Huayu Capsule (tablet), Anluo Huayu Pill, compound Bijiaruangan tablet, etc.
- •The subject (or his/her sexual partner) had no pregnancy plan during the trial period and within 6 months after the trial, voluntarily used effective physical contraception, and had no sperm or egg donation plan.
- •Before the trial, they have understood the nature, significance, potential benefits, inconvenience and potential dangers of the trial in detail, and have voluntarily participated in the clinical trial, have good communication with the researchers, comply with the requirements of the whole study, and have signed a written informed consent form.
排除标准
- •Massive upper gastrointestinal hemorrhage within 3 months before enrolment.
- •Total bilirubin (TBiL) > 3×ULN, or 3×ULN < ALT < 8×ULN and TBiL > 2×ULN.
- •AFP > 100 μg/L although there was no indication of liver cancer.
- •Platelets (PLT) ≤60×109/L.
- •Prothrombin activity (PTA) < 50% or INR > 1.
- •Imaging showed obvious space-occupying lesions in the liver, suggesting tumor.
- •Body mass index (BMI) > 30 kg/m
- •Patients with decompensated liver cirrhosis and liver malignant tumor.
- •Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis.
- •Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders .
- •Women who are pregnant and/or breastfeeding.
- •Have participated in clinical trials of other drugs in the last 3 months.
- •The Investigator considers that there are any conditions that may affect the subjects' informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.
研究组 & 干预措施
Hydronidone group
Experimental
Patients were orally received hydronidone capsules,3 capsules each time, t.i.d. for 52 weeks.
干预措施: Hydronidone capsules (Drug)
The placebo group
Placebo Comparator
Patients were orally received placebo capsules,3 capsules each time, t.i.d. for 52 weeks.
干预措施: The placebo capsules (Drug)
结局指标
主要结局
Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline.
时间窗: 52 weeks
Clinically, the liver pathology scoring system, Ishak system, is widely used make a detailed and accurate assessment of the degree of parenchymal fibrosis or cirrhosis of the nontumorous liver. Ishak system uses a scale of 7 stages (scores 0-6) for the degree of fibrosis; the higher the score, the higher degree the severity of the disease.
次要结局
- Change in liver inflammation grade by greater than or equal to 1 grade after 52 weeks of treatment relative to baseline but with no progression of fibrosis.(52 weeks)
- Change in liver tissue inflammation grade by greater than or equal to 1 grade after 52 weeks of treatment relative to baseline.(52 weeks)
- Change in liver stiffness measurement values via transient elastography LSM (kPa)(Screening period/baseline and weeks 12, 24, 36, and 52 after treatment .)
- Negative conversion (below the lower limit of detection) and the extent of decrease in HBV DNA(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Normalization and the degree of improvement of the indicators of liver function ALT after 52 weeks of treatment.(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:Laboratory examination（AFP test）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:AE(52 weeks)
- Safety endpoints:Laboratory examination（Metabolic panel-AST）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:Laboratory examination（Metabolic panel-GGT）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:Laboratory examination（Metabolic panel-ALP）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:Laboratory examination（Metabolic panel-TP）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:Laboratory examination（Metabolic panel-A）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:Laboratory examination（Metabolic panel-TBiL）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
- Safety endpoints:Laboratory examination（Metabolic panel-DBiL）(Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.)
研究者
研究点 (44)
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