A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Continent Pharmaceutical Co, Ltd.
About this trial
This trial employs a single-arm, open-label, multicenter clinical trial design. All study participants who meet the inclusion/exclusion criteria will receive Hydronidone treatment for 4 weeks. The study includes a screening period (up to 21 days) to assess the eligibility of participants. Eligible participants will enter the treatment period and receive Hydronidone capsules at a dosage of 270 mg TID (30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals) for 28 consecutive days. Participants will return for a follow-up visit on Day 28 (±3 days) after the first dose for safety assessments. All adverse events (AEs) and concomitant medications occurring during the study period must be recorded. After the treatment period, participants will enter a follow-up period to monitor any delayed adverse events. Participants who complete the final follow-up visit are considered to have completed the study. Throughout the study, participants must maintain the stability of all their pre-existing treatment regimens, including antiviral therapy and medications for other comorbid conditions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 70 years (inclusive of 18 and 70 years old, based on the date of signing the informed consent form), regardless of gender.
History of chronic hepatitis B and/or Hepatitis B surface antigen (HBsAg) positive for ≥6 months.
Liver biopsy histopathological examination (results from within 12 months prior to screening are acceptable) with an Ishak score ≥3 or Metavir score ≥F2;
Liver stiffness measurement (Fibroscan, Fibrotouch, or ILivTouch; results from within 1 month prior to screening are acceptable) with a liver stiffness value ≥9.0 kPa;
Disqualifiers
Individuals with a history of specific allergies (e.g., asthma, urticaria, eczema), an allergic constitution (e.g., allergy to drugs or food), or known allergy to Hydroxynidone, pirfenidone, any of their components, or excipients.
Cardiovascular System: Uncontrolled heart failure (NYHA Class III-IV), unstable angina, myocardial infarction within the past 6 months, uncontrolled hypertension, etc.
Renal Diseases: Severe renal insufficiency (eGFR <30 mL/min/1.73 m²), end-stage renal disease, acute kidney injury, etc.
Endocrine and Metabolic Diseases: Poorly controlled diabetes (HbA1c >8.5%), thyroid crisis, etc.
Trial design
Design model
Single group
Treatments tested in this trial
Hydronidone capsules
DrugHydronidone capsules，30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Hydronidone Capsule Group (270 mg)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Adverse Event (AE) refers to any untoward and unintended medical occurrence experienced by a trial participant during treatment or clinical investigation, regardless of causal relationship to the investigational product. Serious Adverse Event (SAE) is a subset of AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, causes persistent or significant disability/incapacity, leads to congenital anomaly/birth defect, or is judged medically important by the investigator. According to the Common Terminology Criteria for Adverse Events, Version 6.0, pulmonary injury is graded, with higher grades indicating more severe symptoms.
Time frame
Within 28 days2
Severity of adverse events (AEs) and serious adverse events (SAEs).
Adverse Event (AE) refers to any untoward and unintended medical occurrence experienced by a trial participant during treatment or clinical investigation, regardless of causal relationship to the investigational product. Serious Adverse Event (SAE) is a subset of AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, causes persistent or significant disability/incapacity, leads to congenital anomaly/birth defect, or is judged medically important by the investigator. According to the Common Terminology Criteria for Adverse Events, Version 6.0, pulmonary injury is graded, with higher grades indicating more severe symptoms.
Time frame
Within 28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Continent Pharmaceutical Co, Ltd.
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Source ClinicalTrials.gov