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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

450

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach

1 country

18 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

Study Start

First participant enrolled

January 28, 2018

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed

27 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed

Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

May 30, 2018

Last Update Submit

June 25, 2018

Conditions

Hepatitis B Liver Fibrosis

Keywords

FibrosisLiver Cirrhosisnon-invasive biopsyhepatitis B virus

Outcome Measures

Primary Outcomes (1)

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.
26 weeks after liver biopsy

Secondary Outcomes (1)

Compare the difference of fibrosis reverse rates between the two groups
26 weeks after liver biopsy

Study Arms (2)

Entecavir Group

ACTIVE COMPARATOR

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

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.

Drug: Entecavir 0.5 mgDrug: Anluohuaxian Pill 12g

Interventions

Entecavir 0.5 mgDRUG

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

Also known as: ETV

Entecavir GroupEntecavir and Anluohuaxian Group

Anluohuaxian Pill 12gDRUG

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

Also known as: ALHX

Entecavir and Anluohuaxian Group

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking University First Hospitallead

Study Sites (18)

Guiqiang Wang

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Beijing Youan Hospital, Capital Medical University