Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Phase 4

Completed

• Conditions: Liver Cirrhosis
• Interventions: Drug: Entecavir; Drug: Thymosin-α

• Registration Number: NCT01943617
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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;

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 606

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir plus thymosin therapy	Thymosin-α	Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year
Entecavir Therapy	Entecavir	Entecavir, 0.5mg, qd, oral, for 2 years
Entecavir plus thymosin therapy	Entecavir	Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of Life	1 and 2-year	Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares
Liver stiffness measurement	1 and 2-year	Liver stiffness measurement change after 1 and 2-year treatment.
Child-Pugh and MELD scores	1 and 2-year	The progress of Child-Pugh and MELD scores after 1 and 2-year treatment
The HBV DNA undetectable rate	1 and 2-year	The HBV DNA undetectable rate after 1 and 2-year treatment

Trial Locations

Locations (21)

302 Military Hospital Of China; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China

Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University; 🇨🇳 Hangzhou, Jiangsu, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

RenjiHospital,Shanghai Jiao Tong University,School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing YouAn Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Shijiazhuang Fifth Hospital; 🇨🇳 Shijiazhuang, Hebei, China

NanfangHospital,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Huashan Hospital FuDan University; 🇨🇳 Shanghai, Shanghai, China

The Affiliated Hospital of Yanbian University; 🇨🇳 Yanbian, Jilin, China

Tongji Hospital, Tongji Medical College ,Huazhong University of Science ＆Technology; 🇨🇳 Wuhan, Hubei, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force; 🇨🇳 Tianjin, Tianjin, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

PeKing University; 🇨🇳 Beijing, Beijing, China