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

Beijing Continent Pharmaceutical Co, Ltd.248 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

248

Conditions

Liver Fibrosis

Interventions

Hydronidone capsulesDRUG

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 capsulesDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 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: 1. Massive upper gastrointestinal hemorrhage within 3 months before enrolment. 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.

Locations (44)

Outcomes

Primary Outcomes

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.

Time frame: 52 weeks

Secondary Outcomes

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.

Scheuer score system is a liver pathology scoring system used for the diagnosis of liver inflammation and fibrosis pathology clinically; In the present trial, Scheuer system for scoring necroinflammatory activitt in chronic hepatitis will be used(G0-G4),the higher the score, the higher degree the severity of the disease.

Time frame: 52 weeks

Change in liver tissue inflammation grade by greater than or equal to 1 grade after 52 weeks of treatment relative to baseline.

Time frame: 52 weeks

Change in liver stiffness measurement values via transient elastography LSM (kPa)

Change in liver stiffness measurement values via transient elastography LSM (kPa) values relative to baseline after 52 weeks of treatment.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 34 more locations