Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.
NCT ID: NCT05115942
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
248 participants
INTERVENTIONAL
2021-12-30
2024-10-22
Brief Summary
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The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hydronidone group
Patients were orally received hydronidone capsules,3 capsules each time, t.i.d. for 52 weeks.
Hydronidone capsules
After randomization, the experimental group were orally received hydronidone capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d,30 min before meals for 52 weeks.
The placebo group
Patients were orally received placebo capsules,3 capsules each time, t.i.d. for 52 weeks.
The placebo capsules
After randomization, The control group were orally received placebo capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d, 30 min before meals for 52 weeks.
Interventions
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Hydronidone capsules
After randomization, the experimental group were orally received hydronidone capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d,30 min before meals for 52 weeks.
The placebo capsules
After randomization, The control group were orally received placebo capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d, 30 min before meals for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6 months.
3. Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3).
4. Positive HBV DNA.
5. ALT \< 8 x ULN (standard upper limit).
6. No antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment.
7. 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.
8. 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.
9. 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.
Exclusion Criteria
2. Total bilirubin (TBiL) \> 3×ULN, or 3×ULN \< ALT \< 8×ULN and TBiL \> 2×ULN.
3. AFP \> 100 μg/L although there was no indication of liver cancer.
4. Platelets (PLT) ≤60×109/L.
5. Prothrombin activity (PTA) \< 50% or INR \> 1.5.
6. Imaging showed obvious space-occupying lesions in the liver, suggesting tumor.
7. Body mass index (BMI) \> 30 kg/m2.
8. Patients with decompensated liver cirrhosis and liver malignant tumor.
9. Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis.
10. Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders .
11. Women who are pregnant and/or breastfeeding.
12. Have participated in clinical trials of other drugs in the last 3 months.
13. 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.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Continent Pharmaceutical Co, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lungen Lu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Jun Cheng, Dr.
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Tsinghua Changgeng Hospital, Beijing
Beijing, Beijing Municipality, China
Chongqing Public Health Medical Treatment Center (Chongqing Infectious Disease Hospital)
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fujian, Fujian, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Lanzhou university first hospital
Lanzhou, Gansu, China
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
Guizhou Provincial People's Hospital
Guizhou, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)
Hangzhou, Hangzhou, China
The First Hospital of Hebei Medical University
Hebei, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Henan, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Yueyang, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of SuZhou University
Suzhou, Jiangsu, China
Taizhou People's Hospital
Taizhou, Jiangsu, China
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Zhenjiang Third People's Hospita
Zhenjiang, Jiangsu, China
Nanchang Ninth Hospital (Nanchang Central Hospital)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
First Hospital of Jilin University
Jilin, Jilin, China
Second Hospital of Jilin University
Jilin, Jilin, China
Yanbian University Affiliated Hospital
Yanbian, Jilin, China
Shanghai General Hospital,Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Jiao Tong University Affiliated Tongren Hospital
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
Luzhou, Sichuan, China
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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KDN-F351-202101
Identifier Type: -
Identifier Source: org_study_id