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Trial · Interventional

CompletedPhase 4Registry data

Optimized Treatment and Regression of HBV-induced Early Cirrhosis

NCTNCT01938820 (opens ClinicalTrials.gov in a new tab)Other id2013ZX10002004-2
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Overview

Status
Completed
Phase
Phase 4
Enrollment
82 participants (actual)
Sponsor
Beijing Friendship Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Jun 2013
Primary completion
Dec 2016
Completion
Dec 2016
First posted
10 Sept 2013 (estimated)
Last update posted
27 Jul 2018
Conditions
Liver Cirrhosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 4

    Optimized Treatment and Regression of HBV-induced Early Cirrhosis

    NCT01938820

    Jun 2013 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.

Interventions

  • entecavirDrug
  • Thymosin-αDrug

Arms2

  • Active comparator

    Entecavir Therapy

    Entecavir monotherapy: entecavir, 0.5mg, qd, oral, for 2 years.

  • Experimental

    Entecavir plus Thymosin-α

    entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Regression of HBV-induced liver cirrhosis

    Time frame · 1.5 to 2 years

    Registry description

    Liver cirrhosis regression of 1 point by Ishak scoring system

Secondary outcomes(4)

  1. Child-Pugh score

    Time frame · 1 year and 2 years

    Registry description

    Child-Pugh score change after 1 and 2-year treatment

  2. HBVDNA undetectable rate

    Time frame · 1 year and 2 years

    Registry description

    The HBVDNA undetectable rate after 1 and 2-year treatment.

  3. Fibroscan value

    Time frame · 1 year and 2 years

    Registry description

    Fibroscan value change after 1 and 2-year treatment

  4. Life Quality

    Time frame · 1 year and 2 years

    Registry description

    Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLu Z, Sun YM, Chen S, Meng T, Wang B, Zhou J, Wu X, Zhao X, Ou X, Kong YY, Jia J, Zhao X, You H. Multiple Low-Level Viraemia Suggest Hindered Liver Fibrosis Regression in Chronic Hepatitis B Patients During Antiviral Therapy. J Viral Hepat. 2024 Dec;31(12):898-902. doi: 10.1111/jvh.14012. Epub 2024 Oct 7. PMID 39373164

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Patients from age 18 to 65 years old; 2. Male or female; 3. Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment; 4. Patients with HBeAg-positive, HBVDNA\>2×10\<3\>IU/ml or patients with HBeAg-negative, HBVDNA\>2×10\<2\> IU/ml； 5. Agree to be followed up regularly; 6. Signature of written informed consent. Exclusion Criteria: 1. Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; 2. Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study; 3. Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases; 4. Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months; 5. Creatinine \>1.5×ULN; 6. Patients with other uncured malignant tumors; 7. Patients with severe diseases of heart, lung, kidney, brain, blood or other organs; 8. Patients with any other reasons not suitable for the study.

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