HEPATITIS B CHRONICNCT07544121
Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis
A study testing Babao Dan Capsule and Babao Dan Capsule simulant in people with HEPATITIS B CHRONIC and Cirrhosis, Liver, run by Nanfang Hospital, Southern Medical University.
Trial summary
This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HEPATITIS B CHRONIC, Cirrhosis, Liver, Hepatocellular Carcinoma (HCC)
- What is being tested?
- Babao Dan Capsule and Babao Dan Capsule simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,034 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Nov 2028
- Phase
- Interventional
- 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
- Voluntarily signed informed consent form
- Aged 18-65 years
- Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun
- Meeting the diagnostic criteria for hepatitis B-related cirrhosis
- aMAP score > 60
Who cannot join
- Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies
- Pregnant or lactating women
- Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)
- Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury
- Severe cardiac, renal, respiratory, or hematopoietic system diseases
- Determined by the investigator to be unsuitable for participation in this trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study
This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score >60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
- Being tested
- Babao Dan Capsule, Babao Dan Capsule simulant
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babao Dan CapsuleDrug
receive compound Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
Babao Dan Capsule simulantDrug
receive compound Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Standard antiviral therapy + Babao Dan Capsule | Experimental | receive Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy. Receives: Drug: Babao Dan Capsule |
| Placebo Comparator: Standard antiviral therapy + Placebo | Placebo comparator | receive Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy. Receives: Drug: Babao Dan Capsule simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up
Measured: From enrollment to the end of treatment at 96 weeks
Secondary outcomes (8)
Incidence of hepatic decompensation events
Measured: From enrollment to the end of treatment at 96 weeks
Trends in the four diagnostic methods of traditional Chinese medicine
Measured: From enrollment to the end of treatment at 96 weeks
Incidence of adverse events (AEs)
Measured: From enrollment to the end of treatment at 96 weeks
Incidence of serious adverse events (SAEs).
Measured: From enrollment to the end of treatment at 96 weeks
FIB-4 index
Measured: From enrollment to the end of treatment at 96 weeks
aspartate aminotransferase (AST)
Measured: From enrollment to the end of treatment at 96 weeks
alanine aminotransferase (ALT)
Measured: From enrollment to the end of treatment at 96 weeks
alpha-fetoprotein (AFP)
Measured: From enrollment to the end of treatment at 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS B CHRONICStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,034 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, Beijing Ditan Hospital, Shenzhen Third People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544121
- Sponsor's protocol ID
- NFEC-2026-138
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07544121
- Acronym / sponsor ID
- NFEC-2026-138
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,034 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, Beijing Ditan Hospital, Shenzhen Third People's Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 22 Apr 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 study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score >60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Standard antiviral therapy + Babao Dan Capsule | Experimental | Drug: Babao Dan Capsulereceive Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy. |
| Placebo Comparator: Standard antiviral therapy + Placebo | Placebo comparator | Drug: Babao Dan Capsule simulantreceive Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily signed informed consent form
- Aged 18-65 years
- Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun
- Meeting the diagnostic criteria for hepatitis B-related cirrhosis
- aMAP score > 60
Key exclusion criteria (6 listed)
- Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies
- Pregnant or lactating women
- Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)
- Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury
- Severe cardiac, renal, respiratory, or hematopoietic system diseases
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 |
|---|---|---|
| Babao Dan Capsulereceive compound Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy. | Drug | Experimental: Standard antiviral therapy + Babao Dan Capsule |
| Babao Dan Capsule simulantreceive compound Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy. | Drug | Placebo Comparator: Standard antiviral therapy + Placebo |
Primary outcome
Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up
Time frame: From enrollment to the end of treatment at 96 weeks
8 secondary outcomes
Incidence of hepatic decompensation events
Time frame: From enrollment to the end of treatment at 96 weeks
Trends in the four diagnostic methods of traditional Chinese medicine
Time frame: From enrollment to the end of treatment at 96 weeks
Incidence of adverse events (AEs)
Time frame: From enrollment to the end of treatment at 96 weeks
Incidence of serious adverse events (SAEs).
Time frame: From enrollment to the end of treatment at 96 weeks
FIB-4 index
Time frame: From enrollment to the end of treatment at 96 weeks
aspartate aminotransferase (AST)
Time frame: From enrollment to the end of treatment at 96 weeks
alanine aminotransferase (ALT)
Time frame: From enrollment to the end of treatment at 96 weeks
alpha-fetoprotein (AFP)
Time frame: From enrollment to the end of treatment at 96 weeks
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 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Babao Dan Capsule and Babao Dan Capsule simulant in people with HEPATITIS B CHRONIC and Cirrhosis, Liver, run by Nanfang Hospital, Southern Medical University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Rong Fan (020-62786534, rongfansmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up (time frame: From enrollment to the end of treatment at 96 weeks). 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 22 Apr 2026.