Clinical trial NCT03568578: A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
Official title: A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B
Liver Fibrosis
Keywords: Fibrosis
Liver Cirrhosis
non-invasive biopsy
hepatitis B virus
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. HBsAg positive for at least 6 months
2. Agree to have liver biopsy
3. Male or female aged 18 to 70 years old -

Exclusion Criteria:

1. Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease
2. Platelet count \< 80 × 10\^9/L
3. Prothrombin activity ≤ 60%
4. Decompensated liver cirrhosis
5. Patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -

Primary outcomes:
measure: Construct a non-invasive model based on laboratory tests
timeFrame: 26 weeks after liver biopsy
Secondary outcomes:
measure: Compare the difference of fibrosis reverse rates between the two groups
timeFrame: 26 weeks after liver biopsy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guiqiang Wang
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi the Fifth People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang First Hospital
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang
role: PRINCIPAL_INVESTIGATOR
References: