Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-12-31

Brief Summary

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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;

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Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir Therapy

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

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

anti-viral therapy

Entecavir plus thymosin therapy

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

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

anti-viral therapy

Thymosin-α

Intervention Type DRUG

anti-viral and antitherapy

Interventions

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Entecavir

anti-viral therapy

Intervention Type DRUG

Thymosin-α

anti-viral and antitherapy

Intervention Type DRUG

Other Intervention Names

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Entecavir dispersible tablets Zadaxin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hong You

Vice-Director Liver Research Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong You, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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