A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.

NCT07412236 | Not Yet Recruiting Phase 3

• 1 other identifier: KDN-F351-202501
• Study Type: interventional
• Target: 1,208
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening/Baseline Period (4 weeks) and a Dosing/Observation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).

Conditions

Liver Fibrosis; Liver Fibrosis in Chronic Hepatitis B

Keywords

LIver Fibrosis in Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinical Endpoint Events

  The clinical endpoint event is a composite event, which includes progression to complications of decompensated cirrhosis (such as ascites, esophageal and gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy, etc.), hepatocellular carcinoma, liver transplantation, and liver disease-related death/all-cause death. The time of event occurrence is determined by whichever occurs first, and the occurrence of any of these events constitutes a clinical endpoint event.

  From the first dose administration to the end of the treatment period (Week 261).

Secondary Outcomes (10)

• Annualized Incidence Rate of Clinical Endpoint Events

  From the first dose administration to the end of the treatment period (Week 261).

• The incidence rates of individual components of the clinical endpoint events

  From the first dose administration to the end of the treatment period (Week 261).

• The annualized incidence rates of individual components of the clinical endpoint events

  From the first dose administration to the end of the treatment period (Week 261).

• Change from baseline in liver stiffness measurement (LSM) by transient elastography (kPa) after treatment.

  From the first dose administration to the end of the treatment period (Week 261).

• Undetectable rate of Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment (below the lower limit of detection).

  From the first dose administration to the end of the treatment period (Week 261).

Study Arms (2)

Hydronidone Capsule Group (270 mg)

EXPERIMENTAL

Treatment Group

Drug: Hydronidone (270mg)

Hydronidone Capsule Group (Placebo Group)

PLACEBO COMPARATOR

Placebo Group

Drug: Hydronidone (Placebo Group)

Interventions

Hydronidone (270mg) DRUG

Dosage: 30 mg/capsule, three capsules taken three times daily, resulting in a total daily therapeutic dose of 270 mg. The medication is administered orally half an hour before meals.

Hydronidone Capsule Group (270 mg)

Hydronidone (Placebo Group) DRUG

Dosage: three capsules taken three times daily.The medication is administered orally half an hour before meals.

Hydronidone Capsule Group (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 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;
• Documented history of chronic hepatitis B and/or positive for hepatitis B surface antigen (HBsAg) for ≥6 months;
• Treatment-naïve or treatment-experienced patients with chronic hepatitis B, defined as follows:
• Treatment-naïve patients must meet all of the following criteria:
• No prior systemic antiviral therapy (e.g., interferon and/or nucleos(t)ide analogues) before randomization;
• Positive for HBV DNA;
• Liver stiffness measurement (LSM) by transient elastography ≥12.4 kPa for treatment-naïve patients with ALT \>2 × ULN; or LSM ≥10.6 kPa for treatment-naïve patients with ALT ≤2 × ULN. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.
• Treatment-experienced patients must meet all of the following criteria:
• A history of ≥6 months of continuous nucleos(t)ide analogue therapy for hepatitis B up to randomization, currently receiving monotherapy with a nucleos(t)ide analogue \[e.g., Tenofovir Alafenamide Fumarate (TAF), Tenofovir Disoproxil Fumarate (TDF), or Entecavir (ETV)\];
• HBV DNA positive or negative is acceptable;
• Liver stiffness measurement (LSM) by transient elastography \>9.0 kPa. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.
• ALT \<8 × ULN;
• No use within 3 months prior to randomization of the following Chinese patent medicines that may have antifibrotic effects: Fuzhenghuayu Capsule (Tablet), Anluohuaxian Pill, Compound Biejia Ruangan Tablet, etc.;
• Subjects (or their sexual partners) have no pregnancy plan during the trial and for 6 months after trial completion, voluntarily agree to use effective physical contraceptive methods, and have no plan to donate sperm or eggs;
• Subjects have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to participation, voluntarily agree to take part in this clinical trial, are able to communicate well with the investigators, agree to comply with all study requirements, and have provided written informed consent.

You may not qualify if:

• Total bilirubin (TBil) \>3 × ULN, or 3 × ULN \< ALT \<8 × ULN with TBil \>2 × ULN;
• Platelet count (PLT) ≤50 × 10⁹/L;
• Prothrombin activity (PTA) \<50% or International Normalized Ratio (INR) \>1.5;
• Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) \>100 μg/L even in the absence of specific signs of hepatocellular carcinoma;
• Patients with decompensated liver cirrhosis (complications including ascites, esophageal and/or gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy) or with hepatic malignancy;
• Patients with chronic hepatitis C or non-viral chronic hepatitis (alcoholic, drug-induced, etc., excluding metabolic dysfunction-associated steatotic liver disease (MASLD));
• History of alcohol abuse or inability to abstain from alcohol recently \[Note: Alcohol abuse is defined as: ① daily ethanol consumption ≥40 g for males or ≥20 g for females for 5 consecutive years; OR ② history of heavy alcohol consumption (\>80 g of ethanol per day) within the past 2 weeks. Ethanol (g) = volume of alcoholic beverage consumed (mL) × alcohol by volume (%) × 0.8\];
• Patients with severe concurrent cardiovascular, pulmonary, renal, endocrine, neurological, or hematological diseases, or psychiatric disorders;
• Pregnant and/or lactating women;
• Participation in any other drug clinical trial within the past 3 months;
• Any condition that, in the investigator's judgment, may affect the subject's ability to provide informed consent or comply with the trial protocol, or participation that may affect the trial results or the subject's own safety.

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

hydronidone

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ling Zhang

CONTACT

+86-13501209210; zhangling@bjcontinent.com

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: January 29, 2026
• First Posted: February 17, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)