NCT07412236
Not yet recruiting
Phase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.
Beijing Continent Pharmaceutical Co, Ltd.1 site in 1 country1,208 target enrollmentStarted: January 30, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Enrollment
- 1,208
- Locations
- 1
- Primary Endpoint
- Incidence of Clinical Endpoint Events
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥
- •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;
Exclusion Criteria
- •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;
Arms & Interventions
Hydronidone Capsule Group (270 mg)
Experimental
Treatment Group
Intervention: Hydronidone (270mg) (Drug)
Hydronidone Capsule Group (Placebo Group)
Placebo Comparator
Placebo Group
Intervention: Hydronidone (Placebo Group) (Drug)
Outcomes
Primary Outcomes
Incidence of Clinical Endpoint Events
Time Frame: From the first dose administration to the end of the treatment period (Week 261).
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.
Secondary Outcomes
- 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).)
- Magnitude of reduction in Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment.(From the first dose administration to the end of the treatment period (Week 261).)
- Normalization rate of improvement in alanine aminotransferase (ALT) levels after treatment.(From the first dose administration to the end of the treatment period (Week 261).)
- Magnitude of improvement in alanine aminotransferase (ALT) levels after treatment.(From the first dose administration to the end of the treatment period (Week 261).)
- Normalization rate of improvement in aspartate aminotransferase (AST) levels after treatment.(From the first dose administration to the end of the treatment period (Week 261).)
- Magnitude of improvement in aspartate aminotransferase (AST) levels after treatment.(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).)
- 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).)
Investigators
Study Sites (1)
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