Chronic Hepatitis B-related Liver FibrosisPhase 2NCT07417553
A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
A Phase 2 study testing Hydronidone capsules in people with Chronic Hepatitis B-related Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B-related Liver Fibrosis
- What is being tested?
- Hydronidone capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 27 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 disproportion, etc.).
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- 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.
Who cannot join
- 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:
- 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).
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- 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:
- 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, 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing Medical University Second Affiliated Hospital
Chongqing, Chongqing Municipality, 400000
About this study
Official title: 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
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.
- Being tested
- Hydronidone capsules
- Keywords
- Chronic Hepatitis B-related liver fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone capsulesDrug
Hydronidone capsules，30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals
| Study group | Role | What they receive |
|---|---|---|
| Hydronidone Capsule Group (270 mg) | Experimental | Receive Hydroxynidone capsules 270 mg TID (30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals) for 28 consecutive days. Receives: Drug: Hydronidone capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 28 days
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.
Measured: Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Apr 2026
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B-related Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417553
- Sponsor's protocol ID
- KDN-F351-202602
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07417553
- Acronym / sponsor ID
- KDN-F351-202602
- Keywords
- Chronic Hepatitis B-related liver fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydronidone Capsule Group (270 mg) | Experimental | Drug: Hydronidone capsulesReceive Hydroxynidone capsules 270 mg TID (30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals) for 28 consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (28 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydronidone capsulesHydronidone capsules，30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals | Drug | Hydronidone Capsule Group (270 mg) |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Within 28 days
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.
Severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Within 28 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydronidone capsules in people with Chronic Hepatitis B-related Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs). (time frame: Within 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.