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Trial registered on ANZCTR


Registration number
ACTRN12614001224617
Ethics application status
Approved
Date submitted
1/08/2014
Date registered
21/11/2014
Date last updated
21/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled trial to study whether telbivudine can prevent virus reactivation and improve the prognosis after liver resection in patients with hepatitis B virus-related hepatocellular carcinoma
Scientific title
A randomized clinical trial to study whether telbivudine can decrease the hepatitis B virus reactivation in patients with hepatocellular carcinoma and HBV-DNA < 2000 IU/ml after liver resection.
Secondary ID [1] 262839 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatitis B virus-related hepatocellulcar carcinoma 270562 0
Condition category
Condition code
Infection 270725 270725 0 0
Other infectious diseases
Cancer 293813 293813 0 0
Liver
Oral and Gastrointestinal 293871 293871 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the telbivudine group received telbivudine 600 mg orally, once a day. The treatment will begin within 1 week after liver resection and last for 1 year. The patient will be monitored by regular laboratory test and follow-up call.
Intervention code [1] 289937 0
Treatment: Drugs
Intervention code [2] 290625 0
Prevention
Comparator / control treatment
Patients in the control group did not recieve telbivudine antivirus treatment, others were same, compared to those in the telbivudine group.
Control group
Active

Outcomes
Primary outcome [1] 292809 0
The primary outcome is the postoperative hepatitis B virus reactivation rates. The copy of HBV-DNA in the blood will be detected 1 month after surgery and then every 3 month. When the HBV-DNA is 10-fold higher or from undectable to be detectable, it is defined as virus reactivation.
Timepoint [1] 292809 0
the time when the hepatitis B virus is reactiveted or the time when the follow-up is ceased (at least 3 years follow-up)
Secondary outcome [1] 309708 0
overall survival
Timepoint [1] 309708 0
paeticipants will be followed up to 3 years post operation or the time when patients died.

Eligibility
Key inclusion criteria
1) Age 18 to 70 years;
2) Positive test for Hepatitis B surface antigen (HBsAg)
3) Serum hepatitis B virus-deoxyribonucleic acid (HBV-DNA) level lower than 2000IU/ml;
4) Serum ALT levels are below the upper limit of normal (ULN);
5) Resectable tumour with Barcelona Clinic Liver Cancer (BCLA) stage 0 or A;
6)Good liver function with Child-Pugh Class A, with no history of encephalopathy, ascites refractory to diuretics, esophago-gastricvaricesor variceal bleeding;
7) Good kidney function (a serum creatinine level < 133 umol/L and creatinine clearance >60 ml/min);
8) The preoperative diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)Positive tests for antibody to hepatitis C virus (HCV-Ab) or human immunodeficiency virus;
2)extrahepatic metastasis;
3)radiologic evidence of invasion into the major portal/hepatic venous branches;
4)previous treatment of HCC;
5)previous history of antiviral therapy;
6)previous history of cancer and chemotherapy
7)previous history of immunosuppressive therapy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We collect the proper patients who accord with the key inclusin criteria and tell a researcher who is not involved in the trial and also don't know the patients. And then that researcher will allocate the patients to each group according to the sequence randomly generated by computer and tell us the result.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence is generated by computer randomly.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6266 0
China
State/province [1] 6266 0
Shanghai

Funding & Sponsors
Funding source category [1] 289695 0
Government body
Name [1] 289695 0
The State Key Project on Infectious Diseases of China: 2012ZX10002010, 2012ZX10002016
Address [1] 289695 0
Num. 225, Changhai Road, Yangpu District, Shanghai City, China. Post code: 200438.
Country [1] 289695 0
China
Funding source category [2] 289696 0
Government body
Name [2] 289696 0
Science Fund for Creative Research Groups, NSFC, China: 81201940
Address [2] 289696 0
Num. 225, Changhai Road, Yangpu District, Shanghai City, China. Post code: 200438.
Country [2] 289696 0
China
Funding source category [3] 289697 0
Government body
Name [3] 289697 0
National Science Foundation of China: 81201555
Address [3] 289697 0
Num. 225, Changhai Road, Yangpu District, Shanghai City, China. Post code: 200438.
Country [3] 289697 0
China
Primary sponsor type
Individual
Name
ZHOU Wei-ping
Address
Eastern Hepatobiliary Surgery Hospital, Num. 225, Changhai Road, Yangpu District, Shanghai City, China. Post code: 200438.
Country
China
Secondary sponsor category [1] 288390 0
Individual
Name [1] 288390 0
Wang Zhen-guang
Address [1] 288390 0
Eastern Hepatobiliary Surgery Hospital, Num. 225, Changhai Road, Yangpu District, Shanghai City, China. Post code: 200438.
Country [1] 288390 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The primary purpose of our study was to see whether preemptive telbivudine treatment in HCC patients with HBV DNA <2000 IU/ml could prevent postoperative HBV reactivation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33021 0
Prof ZHOU Wei-ping
Address 33021 0
The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Yangpu District, Shanghai 200438, China.
Country 33021 0
China
Phone 33021 0
+86-21-81875521 / +86-21-65341828
Fax 33021 0
+86-21-81875529
Email 33021 0
ehphwp@126.com
Contact person for public queries
Name 16268 0
Prof ZHOU Wei-ping
Address 16268 0
The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Yangpu District, Shanghai 200438, China.
Country 16268 0
China
Phone 16268 0
+86-21-81875521 / +86-21-65341828
Fax 16268 0
+86-21-81875529
Email 16268 0
ehphwp@126.com
Contact person for scientific queries
Name 7196 0
Prof ZHOU Wei-ping
Address 7196 0
The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Yangpu District, Shanghai 200438, China.
Country 7196 0
China
Phone 7196 0
+86-21-81875521 / +86-21-65341828
Fax 7196 0
+86-21-81875529
Email 7196 0
ehphwp@126.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary