Skip to main content
OpenTrials
Completed

NCT Number: NCT01943617

Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

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;

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Cirrhosis Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

302 Military Hospital Of China, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients from age 18 to 65 years ;
  • Male or female;
  • Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);
  • endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
  • 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)
  • HBeAg-positive, HBVDNA > 2×10<3> IU/ml or with HBeAg-negative patients, HBVDNA > 2×10<2> IU/ml;
  • Agree to be followed up regularly;
  • Signature of written inform consent.

Exclusion criteria

  • Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
  • Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for medicine in this study;
  • 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;
  • 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;
  • Creatinine > 1.5×ULN;
  • Patients with other uncured malignant tumors;
  • Patients with severe diseases of heart, lung, kidney, brain, blood system or other organs;
  • Patients with any other reasons not suitable for the study.

Treatment and study plan

Entecavir

Drug

anti-viral therapy

Other names: Entecavir dispersible tablets

Thymosin-α

Drug

anti-viral and antitherapy

Other names: Zadaxin

Primary outcomes

  1. Decompensated rate of Liver Cirrhosis after 2 years treatment

    Time frame: 2 years

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

Secondary outcomes

  1. Child-Pugh and MELD scores

    Time frame: 1 and 2-year

    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

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

  3. Liver stiffness measurement

    Time frame: 1 and 2-year

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

  4. Quality of Life

    Time frame: 1 and 2-year

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

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Beijing 302 Hospital
  • Beijing Ditan Hospital
  • Beijing Tiantan Hospital
  • Beijing YouAn Hospital
  • Fifth Hospital of Shijiazhuang City
  • Huashan Hospital
  • Logistics University of Chinese People's Armed Police Forces
  • Nanfang Hospital, Southern Medical University
  • Peking Union Medical College Hospital
  • Peking University
  • Peking University First Hospital
  • Peking University People's Hospital
  • RenJi Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Public Health Clinical Center
  • Shanghai Zhongshan Hospital
  • Sir Run Run Shaw Hospital
  • Tang-Du Hospital
  • The Affiliated Hospital of Yanbian University
  • The First Affiliated Hospital of Shanxi Medical University
  • Tongji Hospital

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2013
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.