Liver FibrosisPhase 4NCT01965418
A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial
A Phase 4 study testing Fufang Biejia Ruangan Tablet in people with Liver Fibrosis and Chronic Hepatitis B, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This research puts liver biopsy as the enrollment screening criteria and the primary efficacy assessment indicators. Patients at different developmental stages of hepatitis B related liver fibrosis are respectively diagnosed and treated by Traditional Chinese medicine to determine optional diagnosis and treatment plan… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fibrosis, Chronic Hepatitis B
- What is being tested?
- Fufang Biejia Ruangan Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria of chronic hepatitis B related liver fibrosis:
- Age from 18 to 65 years old, male or female;
- Consistent with the diagnosis criteria of chronic hepatitis B;
- liver fibrosis(liver biopsy) stage F ≥ 3 (Ishak), HBV DNA ≥ 104 copies / ml (or ≥ 2000 IU / ml) were;
- TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
- Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
- Signed informed consent.
Who cannot join
- liver fibrosis(Liver biopsy) stage F <3 (Ishak);
- Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease;
- Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
- Pregnant or lactating women;
- Patients with allergic constitution or allergic to TCM used;
- Not be prescribed medication, poor compliance, incomplete data affecting the efficacy and safety of those judgments;
- Patients unsuitable for this trial in Researchers' consideration;
- Co-infection with other viral liver disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
302 Military Hospital of China
Beijing, Beijing Municipality, 100039
Hongyan Li, MD, +8618600346925, hongyanlitj@yahoo.com
Feng Yu, MBBS, +861066933461, yfeng0530@163.com
About this study
This research puts liver biopsy as the enrollment screening criteria and the primary efficacy assessment indicators. Patients at different developmental stages of hepatitis B related liver fibrosis are respectively diagnosed and treated by Traditional Chinese medicine to determine optional diagnosis and treatment plan of traditional Chinese medicine to screen the advantage-treated population and to establish a treatment program, which can save national medical resources, for clinical application of Traditional Chinese medicine Diagnosis and Treatment blocking and reversing hepatitis B-related liver fibrosis. The research can help to build automation pathological analysis and diagnosis systems and non-invasive clinical assessment criteria and models of liver fibrosis which can be applied in clinical. It can also help to realize electronic patient data collection and management, to establish patients management centre and follow-up database. Then it will help to improve clinical efficacy of being blocked and reversed chronic hepatitis B related liver fibrosis by Chinese medicine Diagnosis and Treatment program, to reduce the incidence of liver cirrhosis and hepatitis B-related mortality, to prolong patients' survival and improve patients' quality of life, to make clinical efficacy, which is about Traditional Chinese Medicine blocking and revering chronic hepatitis B-related liver fibrosis, increase by 15% or more .
- Conditions
- Liver Fibrosis, Chronic Hepatitis B
- Being tested
- Fufang Biejia Ruangan Tablet, Placebo
- Medical subject headings
- Liver Cirrhosis, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fufang Biejia Ruangan TabletDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Fufang Biejia Ruangan Tablet | Active comparator | Fufang Biejia Ruangan Tablet will be administered to all of subjects in this arm. Receives: Drug: Fufang Biejia Ruangan Tablet |
| placebo | Placebo comparator | placebo of Fufang Biejia Ruangan Tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver histological changes
Measured: before treatment and after 48 weeks twice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongping Yang, Master, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965418
- Sponsor's protocol ID
- 2013ZX10005002
- Status last verified
- Aug 2015
- First submitted
- 16 Oct 2013
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li M, Hao X, Li Y, Zhang C, Chen Y, Yu Z, Li Q, Tan L, Xiang D, Shang Q, Lei C, Chen L, Hu X, Wang J, Liu H, Lu W, Chen Y, Dong Z, Bai W, Yoshida EM, Mendez-Sanchez N, Hu KQ, Qi X, Yang Y, Bi J. Ishak stage 6 fibrosis is more likely to regress than stage 5 in CHB patients undergoing entecavir therapy. Front Med (Lausanne). 2026 Mar 9;13:1765594. doi: 10.3389/fmed.2026.1765594. eCollection 2026.
PubMed 41877798Rong G, Chen Y, Yu Z, Li Q, Bi J, Tan L, Xiang D, Shang Q, Lei C, Chen L, Hu X, Wang J, Liu H, Lu W, Chen Y, Dong Z, Bai W, Yoshida EM, Mendez-Sanchez N, Hu KQ, Qi X, Yang Y. Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients With Chronic Hepatitis B Treated With Entecavir: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Infect Dis. 2022 Mar 15;225(6):1091-1099. doi: 10.1093/infdis/jiaa266.
PubMed 32437567Qu J, Yu Z, Li Q, Chen Y, Xiang D, Tan L, Lei C, Bai W, Li H, Shang Q, Chen L, Hu X, Lu W, Li Z, Chen D, Wang X, Zhang C, Xiao G, Qi X, Chen J, Zhou L, Chen G, Li Y, Zeng Z, Rong G, Dong Z, Chen Y, Lou M, Wang C, Lu Y, Zhang C, Yang Y. Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial. Trials. 2014 Nov 10;15:438. doi: 10.1186/1745-6215-15-438.
PubMed 25381721
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT01965418
- Acronym / sponsor ID
- 2013ZX10005002
- Conditions
- Liver Fibrosis, Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 18 Oct 2013 (estimated)
- 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 research puts liver biopsy as the enrollment screening criteria and the primary efficacy assessment indicators. Patients at different developmental stages of hepatitis B related liver fibrosis are respectively diagnosed and treated by Traditional Chinese medicine to determine optional diagnosis and treatment plan of traditional Chinese medicine to screen the advantage-treated population and to establish a treatment program, which can save national medical resources, for clinical application of Traditional Chinese medicine Diagnosis and Treatment blocking and reversing hepatitis B-related liver fibrosis. The research can help to build automation pathological analysis and diagnosis systems and non-invasive clinical assessment criteria and models of liver fibrosis which can be applied in clinical. It can also help to realize electronic patient data collection and management, to establish patients management centre and follow-up database. Then it will help to improve clinical efficacy of being blocked and reversed chronic hepatitis B related liver fibrosis by Chinese medicine Diagnosis and Treatment program, to reduce the incidence of liver cirrhosis and hepatitis B-related mortality, to prolong patients' survival and improve patients' quality of life, to make clinical efficacy, which is about Traditional Chinese Medicine blocking and revering chronic hepatitis B-related liver fibrosis, increase by 15% or more .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fufang Biejia Ruangan Tablet | Active comparator | Drug: Fufang Biejia Ruangan TabletFufang Biejia Ruangan Tablet will be administered to all of subjects in this arm. |
| placebo | Placebo comparator | Drug: Placeboplacebo of Fufang Biejia Ruangan Tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 65 years old, male or female;
- Consistent with the diagnosis criteria of chronic hepatitis B;
- liver fibrosis(liver biopsy) stage F ≥ 3 (Ishak), HBV DNA ≥ 104 copies / ml (or ≥ 2000 IU / ml) were;
- TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
- Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
Key exclusion criteria (8 listed)
- liver fibrosis(Liver biopsy) stage F <3 (Ishak);
- Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease;
- Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
- Pregnant or lactating women;
- Patients with allergic constitution or allergic to TCM used;
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 |
|---|---|---|
| Fufang Biejia Ruangan Tablet | Drug | Fufang Biejia Ruangan Tablet |
| Placebo | Drug | placebo |
Primary outcome
Liver histological changes
Time frame: before treatment and after 48 weeks twice
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Derived from this study: PubMed 41877798Li M, Hao X, Li Y, Zhang C, Chen Y, Yu Z, Li Q, Tan L, Xiang D, Shang Q, Lei C, Chen L, Hu X, Wang J, Liu H, Lu W, Chen Y, Dong Z, Bai W, Yoshida EM, Mendez-Sanchez N, Hu KQ, Qi X, Yang Y, Bi J. Ishak stage 6 fibrosis is more likely to regress than stage 5 in CHB patients undergoing entecavir therapy. Front Med (Lausanne). 2026 Mar 9;13:1765594. doi: 10.3389/fmed.2026.1765594. eCollection 2026.
- Derived from this study: PubMed 32437567Rong G, Chen Y, Yu Z, Li Q, Bi J, Tan L, Xiang D, Shang Q, Lei C, Chen L, Hu X, Wang J, Liu H, Lu W, Chen Y, Dong Z, Bai W, Yoshida EM, Mendez-Sanchez N, Hu KQ, Qi X, Yang Y. Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients With Chronic Hepatitis B Treated With Entecavir: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Infect Dis. 2022 Mar 15;225(6):1091-1099. doi: 10.1093/infdis/jiaa266.
- Derived from this study: PubMed 25381721Qu J, Yu Z, Li Q, Chen Y, Xiang D, Tan L, Lei C, Bai W, Li H, Shang Q, Chen L, Hu X, Lu W, Li Z, Chen D, Wang X, Zhang C, Xiao G, Qi X, Chen J, Zhou L, Chen G, Li Y, Zeng Z, Rong G, Dong Z, Chen Y, Lou M, Wang C, Lu Y, Zhang C, Yang Y. Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial. Trials. 2014 Nov 10;15:438. doi: 10.1186/1745-6215-15-438.
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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.
Yongping Yang, Master principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fufang Biejia Ruangan Tablet in people with Liver Fibrosis and Chronic Hepatitis B, run by Beijing 302 Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 17 Aug 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongping Yang, Master (0086-13601371542, yongpingyang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver histological changes (time frame: before treatment and after 48 weeks twice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01965418, which also lists 3 linked publications.
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 17 Aug 2015.