Chronic Hepatitis B With Hepatic FibrosisPhase 2NCT07364448
A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
A Phase 2 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 an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis . 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
- 411 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2026to 22 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.
- Patients assessed by the investigator as having chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated cirrhosis) based on histology, imaging, or laboratory markers, meeting any of the following criteria:
- Histologically confirmed diagnosis of hepatic fibrosis (F2 or above);
- Endoscopy showing esophageal or gastric varices or ectopic gastrointestinal varices, excluding non-cirrhotic portal hypertension;
- For chronic hepatitis B patients: liver imaging suggestive of fibrotic features, with liver stiffness measurement (LSM) ≥ 8.5 kPa, or Fibrosis-4 Index (FIB-4) ≥ 1.45; Or for non-alcoholic fatty liver disease patients: LSM ≥ 8.5 kPa or FIB-4 ≥ 1.3; Or for alcoholic liver disease patients: LSM ≥ 8.5 kPa.
- Subjects who agree to use effective contraception measures as specified below during their participation in the trial:
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- Male subjects must consistently employ highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product.
- Female subjects participating in this trial must not be pregnant or lactating and must meet at least one of the following conditions:
- Be a woman of non-childbearing potential (WONCBP), as defined in Appendix 1;
- Be a woman of childbearing potential (WOCBP) who consistently uses highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product, and agrees not to donate eggs for reproductive purposes during this period.
- The patient voluntarily agrees to participate in this trial, demonstrates good compliance, and has the capacity to understand and sign the informed consent form prior to the study.
Who cannot join
- At screening, total bilirubin (TBIL) > 3 × upper limit of normal (ULN), or direct bilirubin (DBIL) > 2 × ULN, or alanine aminotransferase (ALT) > 3 × ULN.
- At screening, alpha-fetoprotein (AFP) > 20 μg/L.
- At screening, platelet count (PLT) ≤ 75 × 10⁹/L, or international normalized ratio (INR) > 1.5.
- History of or current clinical diagnosis of decompensated cirrhosis at screening, or imaging showing significant space-occupying lesions in the liver (intrahepatic nodules > 10 mm), or findings suggestive of malignancy.
- Diagnosis of any other malignancy within the past 5 years prior to screening, except for radically resected and non-recurrent skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix (excluding the cervical cancer cohort), localized prostate cancer, or other carcinomas in situ.
- Use of interferon within 3 months prior to screening.
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- Concurrent severe diseases of the cardiovascular, pulmonary, renal, endocrine, neurological, digestive, or hematopoietic systems, or psychiatric disorders.
- Planned participation in other interventional clinical trials during the study period.
- Participation in any other clinical trials within 3 months prior to screening.
- Pregnant and/or lactating women.
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm Clinical Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis .
Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.
- Being tested
- Hydronidone capsules
- Keywords
- Chronic Hepatitis B with Hepatic Fibrosis, Hydronidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone capsulesDrug
three times a day, 3 capsules each time,
| Study group | Role | What they receive |
|---|---|---|
| Hydronidone Capsule Group | Experimental | All subjects received hydronidone capsules, administered orally three times daily with three capsules per dose, for a total daily treatment dose of 270 mg. The medication was taken half an hour before meals for a total duration of 28 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 posted23 Jan 2026
- Study start12 Mar 2026
- Primary completion22 Jun 2026
- Study completion22 Jun 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Hospital of Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364448
- Sponsor's protocol ID
- KDN-F351-202601
- Status last verified
- Aug 2026
- First submitted
- 16 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
- An Open-label, Single-arm Clinical Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
- ClinicalTrials.gov ID
- NCT07364448
- Acronym / sponsor ID
- KDN-F351-202601
- Keywords
- Chronic Hepatitis B with Hepatic Fibrosis, Hydronidone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Hospital of Jilin University
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 23 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 an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis .
Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.
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 | Experimental | Drug: Hydronidone capsulesAll subjects received hydronidone capsules, administered orally three times daily with three capsules per dose, for a total daily treatment dose of 270 mg. The medication was taken half an hour before meals for a total duration of 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.
- Patients assessed by the investigator as having chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated cirrhosis) based on histology, imaging, or laboratory markers, meeting any of the following criteria:
- Histologically confirmed diagnosis of hepatic fibrosis (F2 or above);
- Endoscopy showing esophageal or gastric varices or ectopic gastrointestinal varices, excluding non-cirrhotic portal hypertension;
- For chronic hepatitis B patients: liver imaging suggestive of fibrotic features, with liver stiffness measurement (LSM) ≥ 8.5 kPa, or Fibrosis-4 Index (FIB-4) ≥ 1.45; Or for non-alcoholic fatty liver disease patients: LSM ≥ 8.5 kPa or FIB-4 ≥ 1.3; Or for alcoholic liver disease patients: LSM ≥ 8.5 kPa.
Key exclusion criteria (11 listed)
- At screening, total bilirubin (TBIL) > 3 × upper limit of normal (ULN), or direct bilirubin (DBIL) > 2 × ULN, or alanine aminotransferase (ALT) > 3 × ULN.
- At screening, alpha-fetoprotein (AFP) > 20 μg/L.
- At screening, platelet count (PLT) ≤ 75 × 10⁹/L, or international normalized ratio (INR) > 1.5.
- History of or current clinical diagnosis of decompensated cirrhosis at screening, or imaging showing significant space-occupying lesions in the liver (intrahepatic nodules > 10 mm), or findings suggestive of malignancy.
- Diagnosis of any other malignancy within the past 5 years prior to screening, except for radically resected and non-recurrent skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix (excluding the cervical cancer cohort), localized prostate cancer, or other carcinomas in situ.
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 capsulesthree times a day, 3 capsules each time, | Drug | Hydronidone Capsule 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 2 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 11 inclusion and 11 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?
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.