drugset / Trial / NCT01943617
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Phase 4
Completed
606 enrolled
Beijing Friendship Hospital
Beijing 302 Hospital · collabBeijing Ditan Hospital · collabBeijing Tiantan Hospital · collabBeijing YouAn Hospital · collabFifth Hospital of Shijiazhuang City · collabHuashan Hospital · collabLogistics University of Chinese People's Armed Police Forces · collabNanfang Hospital, Southern Medical University · collabPeking Union Medical College Hospital · collabPeking University · collabPeking University First Hospital · collabPeking University People's Hospital · collabRenJi Hospital · collabShanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collabShanghai Public Health Clinical Center · collabShanghai Zhongshan Hospital · collabSir Run Run Shaw Hospital · collabTang-Du Hospital · collabThe Affiliated Hospital of Yanbian University · collabThe First Affiliated Hospital of Shanxi Medical University · collabTongji Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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;
Timeline
- Start
- 2013-06
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Wu 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.
- Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entecavir | Small molecule | 0.5 mg | Oral |
| Subject | Thymalfasin | Peptide | 1.6 ug | Other |