Chronic Hepatitis B With Hepatic FibrosisPhase 3NCT07343778
A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
A Phase 3 study testing Hydronidone Capsules in people with Chronic Hepatitis B With Hepatic Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
This is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B With Hepatic 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
- 337 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to 28 Jul 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
- Aged ≥18 years, regardless of gender.
- Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either:
- A prior percutaneous liver biopsy (results within 1 year prior to enrollment are acceptable); or
- Imaging findings (Fibroscan, Fibrotouch, or ultrasound, with results within 3 months prior to enrollment acceptable).
- Alanine aminotransferase (ALT) < 8 × upper limit of normal (ULN).
- Female participants of childbearing potential must have a negative serum pregnancy test. Furthermore, the participant or their partner must agree to employ highly effective contraceptive methods from the start of the trial until 6 months after the last dose of the study drug.
Who cannot join
- History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders affecting drug absorption at the time of screening.
- Total bilirubin (TBIL) > 3 × upper limit of normal (ULN), or ALT > 3 × ULN but < 8 × ULN and TBIL > 2 × ULN.
- Alpha-Fetoprotein (AFP) > 100 μg/L, even in the absence of clinical indications of hepatocellular carcinoma.
- Platelet count (PLT) ≤ 50 × 10⁹/L; Prothrombin activity (PTA) < 50% or International Normalized Ratio (INR) > 1.5.
- Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any infectious event requiring systemic anti-infective therapy.
- Positive test for Human Immunodeficiency Virus antibody (HIV-Ab).
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- History of definite malignant tumors, or clinically significant dysfunction of major organs including heart, lungs, or kidneys, as well as clinically significant severe hepatic dysfunction unrelated to the underlying liver disease (e.g., manifestations of decompensated cirrhosis).
- Pregnant or lactating women.
- Participation in any other clinical trial and receipt of investigational drugs within 3 months prior to screening.
- Any other condition deemed by the investigator as unsuitable for enrollment or likely to prevent completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
This is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Eligible participants will be sequentially enrolled to receive hydronidone capsules 120 mg three times daily (TID) for 28 consecutive days. Participants will return to the hospital on Day 28 after the first dose for a follow-up safety assessment. All adverse events (AEs) and concomitant medications must be recorded during the study period. Participants who complete the Day 28 follow-up visit are considered to have completed the study.
- Being tested
- Hydronidone Capsules
- Keywords
- Chronic hepatitis B with hepatic fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone CapsulesDrug
120mg TID for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Hydronitone Capsules group | Experimental | Eligible subjects who passed screening were enrolled sequentially in this study and received Hydronidone Capsules 120mg TID 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.
Any adverse events occurring in study participants following drug administration.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start16 Mar 2026
- Primary completion28 Jul 2026
- Study completion28 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 With Hepatic 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343778
- Sponsor's protocol ID
- KDN-F351-202508
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 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 Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07343778
- Acronym / sponsor ID
- KDN-F351-202508
- Keywords
- Chronic hepatitis B with hepatic fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 15 Jan 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 is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Eligible participants will be sequentially enrolled to receive hydronidone capsules 120 mg three times daily (TID) for 28 consecutive days. Participants will return to the hospital on Day 28 after the first dose for a follow-up safety assessment. All adverse events (AEs) and concomitant medications must be recorded during the study period. Participants who complete the Day 28 follow-up visit are considered to have completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydronitone Capsules group | Experimental | Drug: Hydronidone CapsulesEligible subjects who passed screening were enrolled sequentially in this study and received Hydronidone Capsules 120mg TID for 28 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
- Aged ≥18 years, regardless of gender.
- Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either:
- A prior percutaneous liver biopsy (results within 1 year prior to enrollment are acceptable); or
- Imaging findings (Fibroscan, Fibrotouch, or ultrasound, with results within 3 months prior to enrollment acceptable).
Key exclusion criteria (10 listed)
- History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders affecting drug absorption at the time of screening.
- Total bilirubin (TBIL) > 3 × upper limit of normal (ULN), or ALT > 3 × ULN but < 8 × ULN and TBIL > 2 × ULN.
- Alpha-Fetoprotein (AFP) > 100 μg/L, even in the absence of clinical indications of hepatocellular carcinoma.
- Platelet count (PLT) ≤ 50 × 10⁹/L; Prothrombin activity (PTA) < 50% or International Normalized Ratio (INR) > 1.5.
- Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any infectious event requiring systemic anti-infective therapy.
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 Capsules120mg TID for 28 consecutive days | Drug | Hydronitone Capsules group |
Primary outcome
Any adverse events occurring in study participants following drug administration.
Time frame: 28 days
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 3 study testing Hydronidone Capsules in people with Chronic Hepatitis B With Hepatic 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 7 inclusion and 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Any adverse events occurring in study participants following drug administration. (time frame: 28 days). 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.