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Trial · Interventional

CompletedPhase 4Registry data

Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

NCTNCT01943617 (opens ClinicalTrials.gov in a new tab)Other id2013ZX10002004-3
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Overview

Status
Completed
Phase
Phase 4
Enrollment
606 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
17 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 Compensated Liver Cirrhosis

    NCT01943617

    Jun 2013 to Dec 2016

Registry summary

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

Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;

Interventions

  • EntecavirDrug
  • Thymosin-αDrug

Arms2

  • Active comparator

    Entecavir Therapy

    Entecavir, 0.5mg, qd, oral, for 2 years

  • Experimental

    Entecavir plus thymosin therapy

    Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Decompensated rate of Liver Cirrhosis after 2 years treatment

    Time frame · 2 years

    Registry description

    Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.

Secondary outcomes(4)

  1. Child-Pugh and MELD scores

    Time frame · 1 and 2-year

    Registry description

    The progress of Child-Pugh and MELD scores after 1 and 2-year treatment

  2. The HBV DNA undetectable rate

    Time frame · 1 and 2-year

    Registry description

    The HBV DNA undetectable rate after 1 and 2-year treatment

  3. Liver stiffness measurement

    Time frame · 1 and 2-year

    Registry description

    Liver stiffness measurement change after 1 and 2-year treatment.

  4. Quality of Life

    Time frame · 1 and 2-year

    Registry description

    Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2021

1 result

Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy.

Wu et al. 2021Hepatology internationalcited by 7

PMID 33460002DOI 10.1007/s12072-020-10114-1PUB-33460002

Full text at the publisher1 result
Publisher pageSee results (1)

Other registry references

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

  • DerivedWu X, Hong J, Zhou J, Sun Y, Li L, Xie W, Piao H, Xu X, Jiang W, Feng B, Chen Y, Xu M, Cheng J, Meng T, Wang B, Chen S, Kong Y, Ou X, You H, Jia J. Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis. Hepatol Int. 2021 Dec;15(6):1318-1327. doi: 10.1007/s12072-021-10240-4. Epub 2021 Nov 29. PMID 34843068

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 ; 2. Male or female; 3. Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions); 1. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension 2. if no endoscopy,should meet two of the four Criterias: * Imaging (US, CT or MRI, et al) showing Surface nodularity: Echogenecity * Platelet (PLT) \< 100×10 \< 9 \>/L , no other interpretation * Albumin (ALB) \< 35.0 g/L, or International Standard Value (INR) \> 1.3 (Prothrombin Time (PT) prolonged \> 3s), or Cholinesterase (CHE) decrease * Liver stiffness measurement value \> 12.4 kpa (ALT\<5×ULN) 4. HBeAg-positive, HBVDNA \> 2×10\<3\> IU/ml or with HBeAg-negative patients, HBVDNA \> 2×10\<2\> IU/ml; 5. Agree to be followed up regularly; 6. Signature of written inform 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 medicine 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 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/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 system or other organs; 8. Patients with any other reasons not suitable for the study.

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