Liver Cirrhosis Due to Hepatitis B VirusPhase 4NCT02241590
Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
A Phase 4 study testing Entecavir + Fuzheng Huayu Tablet in people with Liver Cirrhosis Due to Hepatitis B Virus, run by ShuGuang Hospital at 20 sites in China.
Trial summary
Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, and the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis Due to Hepatitis B Virus
- What is being tested?
- Entecavir + Fuzheng Huayu Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 20 sitesChina
- Study dates
- Sep 2014to Jun 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- More than 6 months history of serum positive HBsAg
- Positive HBV-DNA
- Age 18-60
- Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-virus or anti-fibrosis drug was taken within 6 months.
- Child-Pugh<7 (Stage A)
- The patient or the patient's guardian agrees to participate the trial and sign the informed Consent Form.
Who cannot join
- Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
- Decompensated liver cirrhosis
- HCC
- Liver histology conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced liver injury, parasitic infections, alcoholic liver disease.
- Have psychiatric history or uncontrollable epilepsy patient.
- Uncontrollable diabetic patient
Show all 15Show fewer
- History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle cell disease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
- Severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
- In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrow transplantation and stem cell transplantation.
- Immunocompromised patients: such as HIV infection or take immunosuppressor or glucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3 months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancer chemotherapy) and radioactive therapy.
- Gestation or lactation period women and women who plan to get pregnant during the study period.
- Patient who are allergy to the experimental drug.
- Using history of anti-viral or anti-fibrosis drug within 6 months.
- Patients who are participating other trials.
- Other situation where PI thinks the patient should be excluded.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
The Fifth People's Hospital of Anyang
Anyang, Henan
- Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing
- Recruiting
Beijing Youan Hospital Capital Medical University
Beijing
- Recruiting
China-Japan Friendship Hospital
Beijing
- Recruiting
The First Affiliated Hospital of Hunan University of TCM
Changsha, Hunan
- Recruiting
Huai'an No. 4 People's Hospital
Huai'an, Jiangsu
- Recruiting
Affiliated Hospital of Shandong Univercity of TCM
Jinan, Shandong
- Recruiting
Jingmen No.1 People's Hospital
Jingmen, Hubei
- Recruiting
The Ninth Hospital of Nanchang
Nanchang, Jiangxi
- Recruiting
Guangxi Ruikang Hospital
Nanning, Guangxi
- Recruiting
ShuGuang Hospital
Shanghai, 201203
Zhimin Zhao, PhD, 8621-20256409, kilorair@sina.com
- Recruiting
Ruijin Hospital
Shanghai
- Recruiting
Shanghai Zhongshan Hospital
Shanghai
- Recruiting
Shenzhen Third People's Hospital
Shenzhen
- Recruiting
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei
- Recruiting
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu
- Recruiting
Wenzhou Central Hospital
Wenzhou, Zhejiang
- Recruiting
Hubei Hospital of TCM
Wuhan, Hubei
- Recruiting
Tongji Hospital
Wuhan, Hubei
- Recruiting
Ningxia People's Hospital
Yinchuan, Ningxia
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir in Liver Cirrhosis Patients Due to Hepatitis B Virus
Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix is still required and hopefully improve the efficacy of anti-virals for liver fibrotic patients with HBV, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve the reversion of liver cirrhosis due to HBV.
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV.
- Conditions
- Liver Cirrhosis Due to Hepatitis B Virus
- Being tested
- Entecavir + Placebo, Entecavir + Fuzheng Huayu Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir + PlaceboDrug
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
Entecavir + Fuzheng Huayu TabletDrug
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir + Placebo | Placebo comparator | Tablet with Entrcavir+ Tablet with starch Receives: Drug: Entecavir + Placebo |
| Entecavir + Fuzheng Huayu Tablet | Experimental | Tablet with Entrcavir+ Tablet with Fuzheng Huayu Receives: Drug: Entecavir + Fuzheng Huayu Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of liver fibrosis
The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Cirrhosis Due to Hepatitis B VirusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Guangxi Ruikang Hospital, Hubei Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Huai'an No. 4 People's Hospital, Ruijin Hospital, Shenzhen Third People's Hospital, Beijing Ditan Hospital, Beijing YouAn Hospital, China-Japan Friendship Hospital, Tongji Hospital, Wenzhou Central Hospital, Jingmen No.1 People's Hospital, Affiliated Hospital of Shandong Univercity of TCM, The Ninth Hospital of Nanchang, The People's Hospital of Ningxia, Fifth Hospital of Shijiazhuang City, The Fifth People's Hospital of Suzhou, The Fifth People's Hospital of Anyang
- Responsible party
- Principal investigator, Liu Chenghai, ShuGuang Hospital
- Investigators
- Chenghai Liu, PhD, Study director, ShuGuang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241590
- Sponsor's protocol ID
- SGHLC20140818001
- Status last verified
- Oct 2018
- First submitted
- 12 Sep 2014
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Li ZX, Zhao ZM, Liu P, Zheng QS, Liu CH. Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet () and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial. Chin J Integr Med. 2021 Jul;27(7):509-513. doi: 10.1007/s11655-020-3257-6. Epub 2020 Jun 22.
PubMed 32572776
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir in Liver Cirrhosis Patients Due to Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT02241590
- Acronym / sponsor ID
- SGHLC20140818001
- Conditions
- Liver Cirrhosis Due to Hepatitis B Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Guangxi Ruikang Hospital, Hubei Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Huai'an No. 4 People's Hospital, Ruijin Hospital, Shenzhen Third People's Hospital, Beijing Ditan Hospital, Beijing YouAn Hospital, China-Japan Friendship Hospital, Tongji Hospital, Wenzhou Central Hospital, Jingmen No.1 People's Hospital, Affiliated Hospital of Shandong Univercity of TCM, The Ninth Hospital of Nanchang, The People's Hospital of Ningxia, Fifth Hospital of Shijiazhuang City, The Fifth People's Hospital of Suzhou, The Fifth People's Hospital of Anyang
- Study start
- Sep 2014
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 16 Sep 2014 (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.
Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix is still required and hopefully improve the efficacy of anti-virals for liver fibrotic patients with HBV, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve the reversion of liver cirrhosis due to HBV.
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir + Placebo | Placebo comparator | Drug: Entecavir + PlaceboTablet with Entrcavir+ Tablet with starch |
| Entecavir + Fuzheng Huayu Tablet | Experimental | Drug: Entecavir + Fuzheng Huayu TabletTablet with Entrcavir+ Tablet with Fuzheng Huayu |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- More than 6 months history of serum positive HBsAg
- Positive HBV-DNA
- Age 18-60
- Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-virus or anti-fibrosis drug was taken within 6 months.
- Child-Pugh<7 (Stage A)
Key exclusion criteria (15 listed)
- Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
- Decompensated liver cirrhosis
- HCC
- Liver histology conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced liver injury, parasitic infections, alcoholic liver disease.
- Have psychiatric history or uncontrollable epilepsy patient.
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 |
|---|---|---|
| Entecavir + PlaceboThe subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks. | Drug | Entecavir + Placebo |
| Entecavir + Fuzheng Huayu TabletThe subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks. | Drug | Entecavir + Fuzheng Huayu Tablet |
Primary outcome
Degree of liver fibrosis
Time frame: 48 weeks
The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 32572776Li ZX, Zhao ZM, Liu P, Zheng QS, Liu CH. Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet () and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial. Chin J Integr Med. 2021 Jul;27(7):509-513. doi: 10.1007/s11655-020-3257-6. Epub 2020 Jun 22.
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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.
Chenghai Liu, PhD study director
ShuGuang Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir + Fuzheng Huayu Tablet in people with Liver Cirrhosis Due to Hepatitis B Virus, run by ShuGuang Hospital at 20 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 6 inclusion and 15 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 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 Chenghai Liu, PhD (8621-20256521, chenghailiu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of liver fibrosis (time frame: 48 weeks). 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 NCT02241590, which also lists 1 linked publication.
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 15 Oct 2018.