NCT07364448已完成2 期
An Open-label, Single-arm Clinical Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
Beijing Continent Pharmaceutical Co, Ltd.1 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2026年3月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Any adverse events occurring in study participants following drug administration.
研究概览
简要总结
This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis .
Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.
- •Patients assessed by the investigator as having chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated cirrhosis) based on histology, imaging, or laboratory markers, meeting any of the following criteria:
- •Histologically confirmed diagnosis of hepatic fibrosis (F2 or above);
- •Endoscopy showing esophageal or gastric varices or ectopic gastrointestinal varices, excluding non-cirrhotic portal hypertension;
- •For chronic hepatitis B patients: liver imaging suggestive of fibrotic features, with liver stiffness measurement (LSM) ≥ 8.5 kPa, or Fibrosis-4 Index (FIB-4) ≥ 1.45; Or for non-alcoholic fatty liver disease patients: LSM ≥ 8.5 kPa or FIB-4 ≥ 1.3; Or for alcoholic liver disease patients: LSM ≥ 8.5 kPa.
- •Subjects who agree to use effective contraception measures as specified below during their participation in the trial:
- •Male subjects must consistently employ highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product.
- •Female subjects participating in this trial must not be pregnant or lactating and must meet at least one of the following conditions:
- •Be a woman of non-childbearing potential (WONCBP), as defined in Appendix 1;
- •Be a woman of childbearing potential (WOCBP) who consistently uses highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product, and agrees not to donate eggs for reproductive purposes during this period.
- •The patient voluntarily agrees to participate in this trial, demonstrates good compliance, and has the capacity to understand and sign the informed consent form prior to the study.
排除标准
- •At screening, total bilirubin (TBIL) > 3 × upper limit of normal (ULN), or direct bilirubin (DBIL) > 2 × ULN, or alanine aminotransferase (ALT) > 3 × ULN.
- •At screening, alpha-fetoprotein (AFP) > 20 μg/L.
- •At screening, platelet count (PLT) ≤ 75 × 10⁹/L, or international normalized ratio (INR) > 1.
- •History of or current clinical diagnosis of decompensated cirrhosis at screening, or imaging showing significant space-occupying lesions in the liver (intrahepatic nodules > 10 mm), or findings suggestive of malignancy.
- •Diagnosis of any other malignancy within the past 5 years prior to screening, except for radically resected and non-recurrent skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix (excluding the cervical cancer cohort), localized prostate cancer, or other carcinomas in situ.
- •Use of interferon within 3 months prior to screening.
- •Concurrent severe diseases of the cardiovascular, pulmonary, renal, endocrine, neurological, digestive, or hematopoietic systems, or psychiatric disorders.
- •Planned participation in other interventional clinical trials during the study period.
- •Participation in any other clinical trials within 3 months prior to screening.
- •Pregnant and/or lactating women.
- •Other conditions deemed unsuitable for inclusion by the investigator.
研究组 & 干预措施
Hydronidone Capsule Group
Experimental
All subjects received hydronidone capsules, administered orally three times daily with three capsules per dose, for a total daily treatment dose of 270 mg. The medication was taken half an hour before meals for a total duration of 28 days.
干预措施: Hydronidone capsules (Drug)
结局指标
主要结局
Any adverse events occurring in study participants following drug administration.
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (1)
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