A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis

A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis

A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis (NCT07417553) is a Phase 2 interventional studying Chronic Hepatitis B-related Liver Fibrosis, sponsored by Beijing Continent Pharmaceutical Co, Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Hepatitis B-related Liver Fibrosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Hepatitis B-related Liver Fibrosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18 to 70 years (inclusive of 18 and 70 years old, based on the date of signing the willing to sign a consent form form), regardless of gender. - History of chronic hepatitis B and/or Hepatitis B surface antigen (HBsAg) positive for ≥6 months. - Diagnosed with chronic hepatitis B-related fibrosis by the investigator, meeting any of the following criteria: 1. Liver biopsy histopathological examination (results from within 12 months prior to screening are acceptable) with an Ishak score ≥3 or Metavir score ≥F2; 2. 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; 3. Imaging examination (results from within 12 months prior to screening are acceptable), such as abdominal ultrasound, CT, or MRI, indicating morphological features of cirrhosis (e.g., irregular liver surface, liver lobe disproportion, etc.). - Currently receiving stable antiviral therapy with one or two drugs such as ETV (Entecavir), TAF (Tenofovir Alafenamide), TDF (Tenofovir Disoproxil Fumarate), or TMF (Tenofovir Mefenamide) for ≥6 months. - The study participant agrees, from the time of signing the willing to sign a consent form form until 6 months after the last dose of the study drug, to voluntarily adopt effective contraception for themselves and their partner, with no plans for pregnancy, sperm donation, or egg donation during this period. - Prior to the trial, the participant has fully understood the nature, significance, potential benefits, possible inconveniences, and risks of the study, voluntarily agrees to participate in this clinical trial, can communicate well with the investigator, adheres to all study requirements, and has signed a written willing to sign a consent form form. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. * Diagnosed with chronic hepatitis B-related fibrosis by the investigator, meeting any of the following criteria: 1. Liver biopsy histopathological examination (results from within 12 months prior to screening are acceptable) with an Ishak score ≥3 or Metavir score ≥F2; 2. 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; 3. Imaging examination (results from within 12 months prior to screening are acceptable), such as abdominal ultrasound, CT, or MRI, indicating morphological features of cirrhosis (e.g., irregular liver surface, liver lobe disproportion, etc.). * Currently receiving stable antiviral therapy with one or two drugs such as ETV (Entecavir), TAF (Tenofovir Alafenamide), TDF (Tenofovir Disoproxil Fumarate), or TMF (Tenofovir Mefenamide) for ≥6 months. * The study participant agrees, from the time of signing the informed consent form until 6 months after the last dose of the study drug, to voluntarily adopt effective contraception for themselves and their partner, with no plans for pregnancy, sperm donation, or egg donation during this period. * Prior to the trial, the participant has fully understood the nature, significance, potential benefits, possible inconveniences, and risks of the study, voluntarily agrees to participate in this clinical trial, can communicate well with the investigator, adheres to all study requirements, and has signed a written informed consent form. Exclusion Criteria: * 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. * Individuals currently suffering from the following serious concurrent diseases: 1. Cardiovascular System: Uncontrolled heart failure (NYHA Class III-IV), unstable angina, myocardial infarction within the past 6 months, uncontrolled hypertension, etc. 2. Renal Diseases: Severe renal insufficiency (eGFR \<30 mL/min/1.73 m²), end-stage renal disease, acute kidney injury, etc. 3. Endocrine and Metabolic Diseases: Poorly controlled diabetes (HbA1c \>8.5%), thyroid crisis, etc. 4. Other Chronic Liver Diseases: Alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or severe hepatic steatosis (CAP ≥295 dB/m). 5. Individuals currently receiving anti-tuberculosis treatment or diagnosed with active tuberculosis. * Individuals with a history of decompensated liver cirrhosis (e.g., ascites, hepatic encephalopathy, history of esophageal and gastric variceal bleeding) within 12 months prior to screening, patients with clinically diagnosed liver malignancy, or those with other confirmed malignancies. * Individuals with a history of major upper gastrointestinal bleeding within 6 months prior to screening; those scheduled or requiring immediate upper gastrointestinal endoscopy (gastroscopy) during the trial due to portal hypertension; or cACLD patients with liver stiffness measurement ≥20 kPa and/or platelet count ≤150×10⁹/L. * Individuals with abnormal laboratory test results or clinically significant abnormalities as judged by the investigator: Total bilirubin (TBIL) \>3 × ULN, or 3 × ULN \< ALT \<8 × ULN and TBIL \>2 × ULN. ALT ≥8 × ULN. Platelet count (PLT) ≤50 × 10⁹/L. Prothrombin activity (PTA) \<40% or International Normalized Ratio (INR) \>1.5. * Individuals with a body mass index (BMI) \>32 kg/m². * Individuals with alpha-fetoprotein (AFP) \>100 μg/L in the absence of indicators suggesting hepatocellular carcinoma. * Concurrent users of the following medications: 1. Currently using interferon. 2. Use of known CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) or inducers (e.g., rifampicin, omeprazole) prior to screening, with a washout period less than 7 half-lives of the respective drug. 3. Use of complex traditional Chinese herbal formulations, herbal medicines, or health supplements with unclear interaction profiles. * Individuals with a history of or currently suffering from severe depression, post-traumatic stress disorder (PTSD), other serious mental disorders (e.g., schizophrenia, bipolar disorder, etc.), or cognitive impairment, who are unable to cooperate with medication administration and follow-up. * Individuals with dysphagia, swallowing disorders, or diseases affecting digestion and absorption, such as inflammatory bowel disease, short bowel syndrome, etc. * Individuals testing positive for human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus (HCV) antibody. * Individuals with a history of drug abuse, alcohol abuse, or drug dependence (including methadone maintenance therapy) within 12 months prior to screening. * Pregnant or lactating women. * Individuals who do not agree, from the time of signing the informed consent until 6 months after the last dose of the study drug, to voluntarily adopt effective contraception for themselves and their partner, and have no plans for pregnancy, sperm donation, or egg donation during this period. * Individuals who have participated in other clinical trials and used investigational drugs or medical devices within 3 months prior to screening. * Individuals unable to complete the trial for other reasons, or those deemed unsuitable for participation by the investigator due to other factors.

Treatments Being Tested

DRUG

Hydronidone capsules

Hydronidone capsules，30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chongqing Medical University Second Affiliated Hospital

Chongqing, Chongqing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07417553), the sponsor (Beijing Continent Pharmaceutical Co, Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07417553 clinical trial studying?

Who can participate in NCT07417553?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07417553?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07417553. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07417553. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.