NCT02241590

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_4

Geographic Reach
1 country

20 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

Study Start

First participant enrolled

September 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

4.8 years

First QC Date

September 12, 2014

Last Update Submit

October 12, 2018

Conditions

Liver Cirrhosis Due to Hepatitis B Virus

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 weeks

Study Arms (2)

Entecavir + Placebo

PLACEBO COMPARATOR

Tablet with Entrcavir+ Tablet with starch

Drug: Entecavir + Placebo

Entecavir + Fuzheng Huayu Tablet

EXPERIMENTAL

Tablet with Entrcavir+ Tablet with Fuzheng Huayu

Drug: Entecavir + Fuzheng Huayu Tablet

Interventions

Entecavir + PlaceboDRUG

The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.

Entecavir + Placebo
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.

Entecavir + Fuzheng Huayu Tablet

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Guangxi Ruikang Hospital

Nanning, Guangxi, China

RECRUITING

The Fifth Hospital of Shijiazhuang

Shijiazhuang, Hebei, China

RECRUITING

The Fifth People's Hospital of Anyang

Anyang, Henan, China

RECRUITING

Jingmen No.1 People's Hospital

Jingmen, Hubei, China

RECRUITING

Hubei Hospital of TCM

Wuhan, Hubei, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

The First Affiliated Hospital of Hunan University of TCM

Changsha, Hunan, China

RECRUITING

Huai'an No. 4 People's Hospital

Huai'an, Jiangsu, China

RECRUITING

The Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, China

RECRUITING

The Ninth Hospital of Nanchang

Nanchang, Jiangxi, China

RECRUITING

Ningxia People's Hospital

Yinchuan, Ningxia, China

RECRUITING

Affiliated Hospital of Shandong Univercity of TCM

Jinan, Shandong, China

RECRUITING

Wenzhou Central Hospital

Wenzhou, Zhejiang, China

RECRUITING

Beijing Ditan Hospital Capital Medical University

Beijing, China

RECRUITING

Beijing Youan Hospital Capital Medical University

Beijing, China

RECRUITING

China-Japan Friendship Hospital

Beijing, China

RECRUITING

ShuGuang Hospital

Shanghai, 201203, China

RECRUITING

Ruijin Hospital

Shanghai, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32572776DERIVED

MeSH Terms

Interventions

entecavirfuzheng huayu

Study Officials

  • Chenghai Liu, PhD

    ShuGuang Hospital

    STUDY DIRECTOR

Central Study Contacts

Chenghai Liu, PhD

CONTACT

8621-20256521chenghailiu@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

CN(20)