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New treatment option for Chronic Hepatitis B-related Liver Fibrosis
Official title A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
ClinicalTrials.gov ID: NCT07417553
What this study is testing
What is Hydronidone capsules?
Hydronidone capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic hepatitis b-related liver fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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:
- Liver biopsy histopathological examination (results from within 12 months prior to screening are acceptable) with an Ishak score ≥3 or Metavir score...
- Liver stiffness measurement (Fibroscan, Fibrotouch, or ILivTouch; results from within 1 month prior to screening are acceptable) with a liver...
You likely can't join if
- Individuals with a history of specific allergies (e.g., asthma, urticaria, eczema), an allergic constitution (e.g., allergy to drugs or food), or...
- Individuals currently suffering from the following serious concurrent diseases:
- Cardiovascular System: Uncontrolled heart failure (NYHA Class III-IV), unstable angina, myocardial infarction within the past 6 months, uncontrolled...
- 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.
- Other Chronic Liver Diseases: Alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or severe hepatic steatosis (CAP ≥295...
See the full eligibility 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:
- 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;
- 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...
- 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...
- 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...
- 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...
- Individuals currently suffering from the following serious concurrent diseases:
- 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.
- Other Chronic Liver Diseases: Alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or severe hepatic steatosis (CAP ≥295 dB/m).
- 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...
- 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...
- Individuals with abnormal laboratory test results or clinically significant abnormalities as judged by the investigator: Total bilirubin (TBIL) \>3 × ULN, or 3 × ULN \ 2 × ULN. ALT ≥8 × ULN. Platelet count (PLT) ≤50 ×...
- 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:
- Currently using interferon.
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.