NCT01943617·Phase 4·INTERVENTIONAL

Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Thymosin Alpha-1 Other Completed

Status

Completed

Phase

Phase 4

Enrollment

606

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Entecavir

anti-viral therapy

DRUG

Thymosin-α

anti-viral and antitherapy

Timeline

From registration to results.

First posted
Sep 17, 2013
Study start
Jun 2013
Primary completion
Dec 2016
Study completion
Dec 2016
Results posted
Not reported
Registry updated
Jul 27, 2018

Outcomes

What the study measures.

Primary outcomes

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

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

The HBV DNA undetectable rate

Time frame · 1 and 2-year

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

Liver stiffness measurement

Time frame · 1 and 2-year

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

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

Eligibility

Who can take part.

Minimum age: 18 Years
Maximum age: 65 Years
Sex: ALL
Healthy volunteers: No

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.

Study locations