A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-28

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase II, Double-blinded, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Vitalliver in Patients With Decompensated Cirrhosis

NCT00562783

Hepatitis B Hepatitis C Liver Cirrhosis

COMPLETED PHASE2

Fuzheng Huayu Tablets Reduce the Occurrence of Re-Decompensation Events in Patients With First Decompensation of Hepatitis B-Related Liver Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

NCT07017426

Decompensated Hepatitis B Cirrhosis

NOT_YET_RECRUITING NA

2-Week Study In People With Nonalcoholic Fatty Liver Disease

NCT03513588

Non-alcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease

COMPLETED PHASE1

Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

NCT01728688

Liver Cirrhosis End Stage Liver Disease

UNKNOWN PHASE1/PHASE2

Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study

NCT02457637

Liver Failure, Acute on Chronic

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B Liver Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Entecavir Group

Patients in this arm will be given Entecavir 0.5 mg a day for 2 years.

Group Type ACTIVE_COMPARATOR

Entecavir 0.5 mg

Intervention Type DRUG

Patients in this group will be given Entecavir 0.5 mg a day for 2 years.

Entecavir and Anluohuaxian Group

Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years.

Group Type EXPERIMENTAL

Entecavir 0.5 mg

Intervention Type DRUG

Patients in this group will be given Entecavir 0.5 mg a day for 2 years.

Anluohuaxian Pill 12g

Intervention Type DRUG

Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Entecavir 0.5 mg

Patients in this group will be given Entecavir 0.5 mg a day for 2 years.

Intervention Type DRUG

Anluohuaxian Pill 12g

Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ETV ALHX

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Guiqiang Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guiqiang Wang

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.