Hepatitis BNCT03568578
A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
A study testing Entecavir 0.5 mg and Anluohuaxian Pill 12g in people with Hepatitis B and Liver Fibrosis, run by Peking University First Hospital at 18 sites in China.
Trial summary
The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Liver Fibrosis
- What is being tested?
- Entecavir 0.5 mg and Anluohuaxian Pill 12g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 18 sitesChina
- Study dates
- 28 Jan 2018to 30 Sep 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HBsAg positive for at least 6 months
- Agree to have liver biopsy
- Male or female aged 18 to 70 years old -
Who cannot join
- Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease
- Platelet count < 80 × 10^9/L
- Prothrombin activity ≤ 60%
- Decompensated liver cirrhosis
- Patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Guiqiang Wang
Beijing, Beijing Municipality, 100034
Guiqiang Wang, 13911405123, john131212@126.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hong Zhao, 86-13810765942, minmin2001@gmail.comc
- Recruiting
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Qinghua Meng, 13601398756, wj5773@163.com
- Not yet recruiting
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Fudong Lv, 13681547749, lfd@tom.com
- Recruiting
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Haibin Yu, 13811669802, xiaobenyu2002@163.com
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Anlin Ma, 13910253710, maanlinjc@163.com
- Recruiting
Peking University First hospital
Beijing, Beijing Municipality
Yan Wang, 13601004423, wangyanwang@126.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Hongsong Chen, 13501196710, chenhongsong@pkuph.edu.cn
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Lang Bai, 18980602254, pangbailang@163.com
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Dazhi Zhang, 86-13452382818, zhangdzh@etang.com
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
Rong Fan, 13143522264, rongfansmu@163.com
- Recruiting
Zhejiang First Hospital
Hangzhou, Zhejiang
Weifeng Liang, 13957163061, dr.liangwf@163.com
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Jun Li, 13905175333, dr-lijun@vip.sina.com
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Guo Zhang, 13978839646, zhangguogx@hotmail.com
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
Zhanqing Zhang, 18916039958, doctorzzqsphc@163.com
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality
Honglian Gui, 13564725017, lillian_ghl@163.com
- Recruiting
Wuxi the Fifth People's Hospital
Wuxi, Jiangsu
Lihua Huang, 13601513551, huanglihua@sina.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Yi Kang, 13938553839, 13938553839@163.com
About this study
The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.
Read the detailed description
450 patients who are infected with hepatitis B virus for at least 6 months will be included in the study. They will be divided into two groups. One group will be treated with Entecavir while another treated with Entecavir and Anluohuaxian Pill. Liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. Furthermore, the samples will be used to evaluate if Anluohuaxian Pill could reverse liver fibrosis and cirrhosis.
- Conditions
- Hepatitis B, Liver Fibrosis
- Being tested
- Entecavir 0.5 mg, Anluohuaxian Pill 12g
- Keywords
- Fibrosis, Liver Cirrhosis, non-invasive biopsy, hepatitis B virus
- Medical subject headings
- Hepatitis B, Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir 0.5 mgDrug
Also called ETV
Patients in this group will be given Entecavir 0.5 mg a day for 2 years.
Anluohuaxian Pill 12gDrug
Also called ALHX
Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Entecavir Group | Active comparator | Patients in this arm will be given Entecavir 0.5 mg a day for 2 years. Receives: Drug: Entecavir 0.5 mg |
| Entecavir and Anluohuaxian Group | Experimental | Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years. Receives: Drug: Entecavir 0.5 mg; Drug: Anluohuaxian Pill 12g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct a non-invasive model based on laboratory tests
We will measure the following biomarkers: TIMP1，CXCL10，CD25，YKL-40，collagen IV，von Willebrand Factor，TGF-β1，ANGPTL2，MMP-9，IL-2R，PDGF-AA，PDGF-BB，TGF-a，LN，MMP-1, soluble CD163 and CXCL9. To formulate the predictive models for detecting significant fibrosis (Ishak fibrosis score ≥3)， univariate analysis was performed on variables between patients with and without significant fibrosis. The significant variables (p<0.05) were then subjected to multivariate stepwise logistic regression, using backward approaches, and were combined using the logistic regression function. The diagnostic value of each regression model was assessed using receiver operating characteristics curves.
Measured: 26 weeks after liver biopsy
Secondary outcomes (1)
Compare the difference of fibrosis reverse rates between the two groups
Liver biopsy samples will be evaluated by Ishak fibrosis score. Then we compare the difference of fibrosis reverse rates between the two groups by Ishak fibrosis score.
Measured: 26 weeks after liver biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start28 Jan 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Sep 2021 (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 Hepatitis BStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guiqiang Wang, Peking University First Hospital
- Investigators
- Guiqiang Wang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568578
- Sponsor's protocol ID
- 2017ZX10203202002
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Dong XQ, Cao LH, Zhang ZQ, Zhao WF, Shang QH, Zhang DZ, Ma AL, Xie Q, Gui HL, Zhang G, Liu YX, Shang J, Xie SB, Liu YQ, Zhang C, Wang GQ, Zhao H; China HepB Related Fibrosis Assessment Research Group. Factors associated with persistent positive in HBV DNA level in patients with chronic Hepatitis B receiving entecavir treatment. Front Cell Infect Microbiol. 2023 Jun 16;13:1151899. doi: 10.3389/fcimb.2023.1151899. eCollection 2023.
PubMed 37396307
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
- ClinicalTrials.gov ID
- NCT03568578
- Acronym / sponsor ID
- 2017ZX10203202002
- Conditions
- Hepatitis B, Liver Fibrosis
- Keywords
- Fibrosis, Liver Cirrhosis, non-invasive biopsy, hepatitis B virus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 26 Jun 2018 (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.
The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.
Detailed description
450 patients who are infected with hepatitis B virus for at least 6 months will be included in the study. They will be divided into two groups. One group will be treated with Entecavir while another treated with Entecavir and Anluohuaxian Pill. Liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. Furthermore, the samples will be used to evaluate if Anluohuaxian Pill could reverse liver fibrosis and cirrhosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir Group | Active comparator | Drug: Entecavir 0.5 mgPatients in this arm will be given Entecavir 0.5 mg a day for 2 years. |
| Entecavir and Anluohuaxian Group | Experimental | Drug: Entecavir 0.5 mg, Drug: Anluohuaxian Pill 12gPatients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HBsAg positive for at least 6 months
- Agree to have liver biopsy
- Male or female aged 18 to 70 years old -
Key exclusion criteria (5 listed)
- Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease
- Platelet count < 80 × 10^9/L
- Prothrombin activity ≤ 60%
- Decompensated liver cirrhosis
- Patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -
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 0.5 mgAlso: ETVPatients in this group will be given Entecavir 0.5 mg a day for 2 years. | Drug | Entecavir Group, Entecavir and Anluohuaxian Group |
| Anluohuaxian Pill 12gAlso: ALHXPatients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years | Drug | Entecavir and Anluohuaxian Group |
Primary outcome
Construct a non-invasive model based on laboratory tests
Time frame: 26 weeks after liver biopsy
We will measure the following biomarkers: TIMP1，CXCL10，CD25，YKL-40，collagen IV，von Willebrand Factor，TGF-β1，ANGPTL2，MMP-9，IL-2R，PDGF-AA，PDGF-BB，TGF-a，LN，MMP-1, soluble CD163 and CXCL9. To formulate the predictive models for detecting significant fibrosis (Ishak fibrosis score ≥3)， univariate analysis was performed on variables between patients with and without significant fibrosis. The significant variables (p<0.05) were then subjected to multivariate stepwise logistic regression, using backward approaches, and were combined using the logistic regression function. The diagnostic value of each regression model was assessed using receiver operating characteristics curves.
1 secondary outcome
Compare the difference of fibrosis reverse rates between the two groups
Time frame: 26 weeks after liver biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Derived from this study: PubMed 37396307Li J, Dong XQ, Cao LH, Zhang ZQ, Zhao WF, Shang QH, Zhang DZ, Ma AL, Xie Q, Gui HL, Zhang G, Liu YX, Shang J, Xie SB, Liu YQ, Zhang C, Wang GQ, Zhao H; China HepB Related Fibrosis Assessment Research Group. Factors associated with persistent positive in HBV DNA level in patients with chronic Hepatitis B receiving entecavir treatment. Front Cell Infect Microbiol. 2023 Jun 16;13:1151899. doi: 10.3389/fcimb.2023.1151899. eCollection 2023.
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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.
Guiqiang Wang principal investigator
Peking University First Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entecavir 0.5 mg and Anluohuaxian Pill 12g in people with Hepatitis B and Liver Fibrosis, run by Peking University First Hospital at 18 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 3 inclusion and 5 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guiqiang Wang (13911405123, john131212@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct a non-invasive model based on laboratory tests (time frame: 26 weeks after liver biopsy). 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 NCT03568578, 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 27 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.