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;

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

606

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach

1 country

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

June 1, 2013

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed

12 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

3.5 years

First QC Date

September 5, 2013

Last Update Submit

July 26, 2018

Conditions

Liver Cirrhosis

Keywords

Liver CirrhosisHepatitis BCompensationEfficacy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Child-Pugh and MELD scores
1 and 2-year
The HBV DNA undetectable rate
1 and 2-year
Liver stiffness measurement
1 and 2-year
Quality of Life
1 and 2-year

Study Arms (2)

Entecavir Therapy

ACTIVE COMPARATOR

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

Drug: Entecavir

Entecavir plus thymosin therapy

EXPERIMENTAL

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

Drug: EntecavirDrug: Thymosin-α

Interventions

EntecavirDRUG

anti-viral therapy

Also known as: Entecavir dispersible tablets

Entecavir TherapyEntecavir plus thymosin therapy

Thymosin-αDRUG

anti-viral and antitherapy

Also known as: Zadaxin

Entecavir plus thymosin therapy

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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);
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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Beijing Friendship Hospitallead
Peking University People's Hospitalcollaborator
RenJi Hospitalcollaborator
Peking Universitycollaborator
Shanghai Zhongshan Hospitalcollaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
Shanghai Public Health Clinical Centercollaborator
Nanfang Hospital, Southern Medical Universitycollaborator
Sir Run Run Shaw Hospitalcollaborator
Beijing YouAn Hospitalcollaborator
Peking University First Hospitalcollaborator
Beijing 302 Hospitalcollaborator
Peking Union Medical College Hospitalcollaborator
Beijing Ditan Hospitalcollaborator
Beijing Tiantan Hospitalcollaborator
Huashan Hospitalcollaborator
Tongji Hospitalcollaborator
Tang-Du Hospitalcollaborator
Fifth Hospital of Shijiazhuang Citycollaborator
Logistics University of Chinese People's Armed Police Forcescollaborator
The First Affiliated Hospital of Shanxi Medical Universitycollaborator
The Affiliated Hospital of Yanbian Universitycollaborator

Study Sites (21)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

302 Military Hospital Of China

Beijing, Beijing Municipality, 100039, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

PeKing University

Beijing, Beijing Municipality, 100871, China

Location

NanfangHospital,Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Shijiazhuang Fifth Hospital

Shijiazhuang, Hebei, 50021, China

Location

Tongji Hospital, Tongji Medical College ,Huazhong University of Science ＆Technology

Wuhan, Hubei, 300030, China

Location

Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University

Hangzhou, Jiangsu, 310016, China

Location

The Affiliated Hospital of Yanbian University

Yanbian, Jilin, 133000, China

Location

RenjiHospital,Shanghai Jiao Tong University,School of Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Huashan Hospital FuDan University

Shanghai, Shanghai Municipality, 200040, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 30001, China

Location

The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force

Tianjin, Tianjin Municipality, 300162, China

Location

Related Publications (2)

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.
PMID: 34843068DERIVED
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.
PMID: 33460002DERIVED

MeSH Terms

Conditions

Liver CirrhosisHepatitis B

Interventions

entecavirThymalfasin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Intervention Hierarchy (Ancestors)

ThymosinThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

Hong You, Doctor
Beijing Friendship Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Vice-Director Liver Research Centre

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 17, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 27, 2018

Record last verified: 2018-07

Locations

CN(21)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Entecavir Therapy

Entecavir plus thymosin therapy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (21)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations