Liver FibrosisPhase 3NCT05905172
Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
A Phase 3 study testing Hydronidone capsules in people with Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 23 sites in China.
Trial summary
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B". Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Hydronidone capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 23 sitesChina
- Study dates
- 12 Aug 2023to 20 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the Phase III trial of this project (Protocol Number: KDN-F351- 202101 ，ClinicalTrials.gov ID: NCT05115942 ), complete the main treatment course and the last visit;
- Before the trial, the subject understood the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, volunteered to participate in the clinical trial, was able to communicate well with the investigator, comply with the requirements of the whole study, and signed a written informed consent.
Who cannot join
- One of any clinical endpoints occurred during the phase III trial (Note: for non cirrhotic patients, Clinical endpoints include progression to cirrhosis,decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy], hepatocellular carcinoma, liver transplantation or liver disease related death / all-cause death; For patients with liver cirrhosis, Clinical endpoints include complications of decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, or liver disease-related death / all-cause death);
- Patients with malignant tumors other than hepatocellular carcinoma and with an expected survival period of less than 1 year;
- Any opinion of the investigator that may affect the subject to provide informed consent or follow the trial protocol, or participation in the trial may affect the trial results or their own safety.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100020
Wen Xie
- Recruiting
Beijing youan hospital, the capital of the capital
Beijing
Sujun Zheng
- Recruiting
Tsinghua Changgeng Hospital, Beijing
Beijing
Yuan Huang
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Wei Li
- Recruiting
The Second Xiangya Hospital, Central South University
Changsha
Yongfang Jiang
- Recruiting
Xiangya Hospital, Central South University
Changsha
Yan Huang
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Yongguo Li
- Recruiting
Three Gorges Hospital affiliated to Chongqing University
Chongqing
Xuan An
- Recruiting
Guizhou Provincial People's Hospital
Guizhou
Xinhua Luo
- Recruiting
Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)
Hangzhou
Jianfeng Bao
- Recruiting
Henan Provincial People's Hospital
Henan
Jia Shang
- Recruiting
Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
Luzhou
Jing Wang
- Recruiting
Nanchang Ninth Hospital (Nanchang Central Hospital)
Nanchang
Long Xu
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Xiaoping Wu
- Recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing
Jun Li
- Recruiting
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo
Liyun Fu
- Recruiting
Shanghai General Hospital,Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201620
Lungen Lu, Dr., 021-37798576, lungenlu1965@163.com
- Recruiting
Huashan Hospital affiliated to Fudan University
Shanghai
Jiming Zhang
- Recruiting
Shenzhen Third People's Hospital
Shenzhen
Qingxian Cai
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang
Xinwen Song
- Recruiting
Yanbian University Affiliated Hospital
Yanbian
Ning Chen
- Recruiting
Zhenjiang Third People's Hospita
Zhenjiang
Youwen Tan
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi
Yawen Luo
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase IIIb Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B".
The main objective of this study is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
Read the detailed description
Nowadays, there is no satisfactory treatment and drug for liver fibrosis, so the etiology treatment of liver fibrosis and cirrhosis is the most important treatment. However, the etiology and treatment can not completely prevent the progression of liver fibrosis, and liver cirrhosis and liver cancer still occur after antiviral treatment. Although some drugs in domestic and foreign clinical trials have reported the effect of treating liver fibrosis, there is no recognized effective chemical drugs or biological agents against liver fibrosis. According to the available evidence, hydronidone capsules can effectively reduce the severity of liver fibrosis, which is expected to further reduce the risk of clinical endpoint events. Since the clinical benefit from the improvement of liver fibrosis usually takes a long time to observe, this trial takes an extended treatment approach to continuously evaluate the clinical benefit of subjects undergoing long-term treatment with hydronidone capsules in patients with liver fibrosis.
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B". Subjects who have completed the Phase III, placebo-controlled design, double-blind, can enter the study and continue treatment according to the original treatment protocol.The aim is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
The test group received hydronidone capsules three times a day at a daily dose of 270 mg and oral medication half an hour before the meal. The control group received placebo capsules three times a day, half an hour before the meal.Both the test and control groups received entecavir antiviral therapy as basic treatment, once daily at 0.5 mg each, by fasting oral administration. If the subject is not suitable for entecavir, the investigator will decide on the corresponding antiviral treatment according to the subject's specific condition. Discontinuation criteria for entecavir: According to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition), the American Association for the Study of Liver Disease (AASLD) and the European Association for Liver Disease (EASL) management guidelines.
Visit examination items: clinical laboratory tests (routine ALT) every 6 months (for ALT and AST, additional tests as appropriate), HBVDNA, hepatitis B, transient elastography examination, etc. In order to improve subject compliance, the investigator may increase or reduce the examination frequency or items, and at least 1 year to reducing the frequency. Additional according to the actual situation
- Conditions
- Liver Fibrosis
- Being tested
- Hydronidone capsules, The placebo capsules
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone capsulesDrug
Also called F351
After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.
The placebo capsulesDrug
Also called N
After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Hydronidone group | Experimental | Patients were given three capsules of hydronidone three times a day for 5 years. Receives: Drug: Hydronidone capsules |
| The placebo group | Placebo comparator | Patients were given three capsules of placebo three times a day for 5 years. Receives: Drug: The placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of clinical endpoint events (defined as the occurrence of any clinical endpoint event).
For non-cirrhotic patients, clinical endpoints include progression to cirrhosis, decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy, etc.], hepatocellular carcinoma, liver transplantation or liver disease-related death / all-cause death; for patients with cirrhosis, clinical endpoints include occurrence of decompensated cirrhosis complications, hepatocellular carcinoma, liver transplantation or liver disease-related death or all-cause death.
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 Aug 2023
- Primary completion20 Jun 2028 (estimated)
- Study completion20 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test group: hydronidone capsules, three times a day, 3 capsules each time，oral，daily therapeutic dose of 270 mg, half an hour before the meal Control group: placebo capsules, three times a day, 3 capsules each time，oral，half an hour before the meal. Basic treatment: Both test and control groups were treated with entecavir antiviral therapy, once daily, 0.5 mg per time, oral. In case of drug resistance or other conditions requiring dose adjustment, the investigator may adjust the dose and type of basic treatment drug appropriately.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lungen Lu, Dr, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineJun Cheng, Dr, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905172
- Sponsor's protocol ID
- KDN-F351-202201
- Status last verified
- May 2025
- First submitted
- 7 Jun 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase IIIb Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT05905172
- Acronym / sponsor ID
- KDN-F351-202201
- Conditions
- Liver Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 20 Jun 2028 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 15 Jun 2023 (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 study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B".
The main objective of this study is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
Detailed description
Nowadays, there is no satisfactory treatment and drug for liver fibrosis, so the etiology treatment of liver fibrosis and cirrhosis is the most important treatment. However, the etiology and treatment can not completely prevent the progression of liver fibrosis, and liver cirrhosis and liver cancer still occur after antiviral treatment. Although some drugs in domestic and foreign clinical trials have reported the effect of treating liver fibrosis, there is no recognized effective chemical drugs or biological agents against liver fibrosis. According to the available evidence, hydronidone capsules can effectively reduce the severity of liver fibrosis, which is expected to further reduce the risk of clinical endpoint events. Since the clinical benefit from the improvement of liver fibrosis usually takes a long time to observe, this trial takes an extended treatment approach to continuously evaluate the clinical benefit of subjects undergoing long-term treatment with hydronidone capsules in patients with liver fibrosis.
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B". Subjects who have completed the Phase III, placebo-controlled design, double-blind, can enter the study and continue treatment according to the original treatment protocol.The aim is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
The test group received hydronidone capsules three times a day at a daily dose of 270 mg and oral medication half an hour before the meal. The control group received placebo capsules three times a day, half an hour before the meal.Both the test and control groups received entecavir antiviral therapy as basic treatment, once daily at 0.5 mg each, by fasting oral administration. If the subject is not suitable for entecavir, the investigator will decide on the corresponding antiviral treatment according to the subject's specific condition. Discontinuation criteria for entecavir: According to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition), the American Association for the Study of Liver Disease (AASLD) and the European Association for Liver Disease (EASL) management guidelines.
Visit examination items: clinical laboratory tests (routine ALT) every 6 months (for ALT and AST, additional tests as appropriate), HBVDNA, hepatitis B, transient elastography examination, etc. In order to improve subject compliance, the investigator may increase or reduce the examination frequency or items, and at least 1 year to reducing the frequency. Additional according to the actual situation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Test group: hydronidone capsules, three times a day, 3 capsules each time，oral，daily therapeutic dose of 270 mg, half an hour before the meal Control group: placebo capsules, three times a day, 3 capsules each time，oral，half an hour before the meal. Basic treatment: Both test and control groups were treated with entecavir antiviral therapy, once daily, 0.5 mg per time, oral. In case of drug resistance or other conditions requiring dose adjustment, the investigator may adjust the dose and type of basic treatment drug appropriately.
| Arm | Type | Receives |
|---|---|---|
| Hydronidone group | Experimental | Drug: Hydronidone capsulesPatients were given three capsules of hydronidone three times a day for 5 years. |
| The placebo group | Placebo comparator | Drug: The placebo capsulesPatients were given three capsules of placebo three times a day for 5 years. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participate in the Phase III trial of this project (Protocol Number: KDN-F351- 202101 ，ClinicalTrials.gov ID: NCT05115942 ), complete the main treatment course and the last visit;
- Before the trial, the subject understood the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, volunteered to participate in the clinical trial, was able to communicate well with the investigator, comply with the requirements of the whole study, and signed a written informed consent.
Key exclusion criteria (3 listed)
- One of any clinical endpoints occurred during the phase III trial (Note: for non cirrhotic patients, Clinical endpoints include progression to cirrhosis,decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy], hepatocellular carcinoma, liver transplantation or liver disease related death / all-cause death; For patients with liver cirrhosis, Clinical endpoints include complications of decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, or liver disease-related death / all-cause death);
- Patients with malignant tumors other than hepatocellular carcinoma and with an expected survival period of less than 1 year;
- Any opinion of the investigator that may affect the subject to provide informed consent or follow the trial protocol, or participation in the trial may affect the trial results or their own safety.
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 capsulesAlso: F351After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years. | Drug | Hydronidone group |
| The placebo capsulesAlso: NAfter randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 5 years. | Drug | The placebo group |
Primary outcome
Cumulative incidence of clinical endpoint events (defined as the occurrence of any clinical endpoint event).
Time frame: 5years
For non-cirrhotic patients, clinical endpoints include progression to cirrhosis, decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy, etc.], hepatocellular carcinoma, liver transplantation or liver disease-related death / all-cause death; for patients with cirrhosis, clinical endpoints include occurrence of decompensated cirrhosis complications, hepatocellular carcinoma, liver transplantation or liver disease-related death or all-cause death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Lungen Lu, Dr principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Jun Cheng, Dr principal investigator
Beijing Ditan Hospital
23 sites 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 Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 23 sites 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Zhang, Dr (+86-13501209210, zhangling@bjcontinent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of clinical endpoint events (defined as the occurrence of any clinical endpoint event). (time frame: 5years). 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 4 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.