Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.

NCT05115942 | Completed Phase 3

• 1 other identifier: KDN-F351-202101
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 44

Brief Summary

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.

Conditions

Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline.

  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.

  52 weeks

Secondary Outcomes (14)

• 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.

Study Arms (2)

Hydronidone group

EXPERIMENTAL

Patients were orally received hydronidone capsules,3 capsules each time, t.i.d. for 52 weeks.

Drug: Hydronidone capsules

The placebo group

PLACEBO COMPARATOR

Patients were orally received placebo capsules,3 capsules each time, t.i.d. for 52 weeks.

Drug: The placebo capsules

Interventions

Hydronidone capsules DRUG

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.

Also known as: F351

Hydronidone group

The placebo capsules DRUG

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.

Also known as: N

The placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 \> 1.5.
• Imaging showed obvious space-occupying lesions in the liver, suggesting tumor.
• Body mass index (BMI) \> 30 kg/m2.
• 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.

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (44)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

Location

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing You 'an Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Tsinghua Changgeng Hospital, Beijing

Beijing, Beijing Municipality, China

Location

Chongqing Public Health Medical Treatment Center (Chongqing Infectious Disease Hospital)

Chongqing, Chongqing Municipality, China

Location

Chongqing Three Gorges Central Hospital

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fujian, Fujian, China

Location

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, China

Location

Lanzhou university first hospital

Lanzhou, Gansu, China

Location

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Location

Guizhou Provincial People's Hospital

Guizhou, Guizhou, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)

Hangzhou, Hangzhou, China

Location

The First Hospital of Hebei Medical University

Hebei, Hebei, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Henan Provincial People's Hospital

Henan, Henan, China

Location

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China

Location

Zhengzhou Sixth People's Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

Location

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of University of South China

Yueyang, Hunan, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of SuZhou University

Suzhou, Jiangsu, China

Location

Taizhou People's Hospital

Taizhou, Jiangsu, China

Location

Wuxi Fifth People's Hospital

Wuxi, Jiangsu, China

Location

Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, China

Location

Zhenjiang Third People's Hospita

Zhenjiang, Jiangsu, China

Location

Nanchang Ninth Hospital (Nanchang Central Hospital)

Nanchang, Jiangxi, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

First Hospital of Jilin University

Jilin, Jilin, China

Location

Second Hospital of Jilin University

Jilin, Jilin, China

Location

Yanbian University Affiliated Hospital

Yanbian, Jilin, China

Location

Shanghai General Hospital,Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 201620, China

Location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanghai Jiao Tong University Affiliated Tongren Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Location

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

Luzhou, Sichuan, China

Location

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

hydronidone; 5-methyl-1-(4-hydroxylphenyl)-2-(1H)-pyridone

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lungen Lu, Dr.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jun Cheng, Dr.

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: November 10, 2021
• Study Start: December 30, 2021
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (44)