Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000840987
Ethics application status
Approved
Date submitted
7/07/2011
Date registered
9/08/2011
Date last updated
16/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized clinical trial of adefovir to treat patients with hepatitis B-related hepatocellular carcinoma after radical tumor resection
Scientific title
a randomized clinical trial to study whether adefovir can improve the prognosis of HCC patients with HBV-DNA>=10000 copies/ml
Secondary ID [1] 253599 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
whether adefovir can prolong the disease-free survival and overall survival of hepatocellular carcinoma patients with HBV-DNA >=10000 copies/ml 261159 0
Condition category
Condition code
Cancer 259313 259313 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
we give adefovir 10mg oral tablet, once a day to patients in treatment group.Overall duration of antivirus treatment is according to the guideline of chronic hepatitis B. The indicatons to stop antivirus treatment are as follows:1.to the patients with HBeAg(+), they should take medicine for 6-12 months after HBeAg(+) becoming HBeAg(-) and then can stop the antivirus treatment;2.to the patients with HBeAg(-), when HBV-DNA is undetectable for three times with a interval of 6 months,they can choose to stop treatment;3.to cirrhosis patients, we recommend taking antivirus treatment for whole life.
Intervention code [1] 258020 0
Treatment: Drugs
Comparator / control treatment
we give no anti-virus treatment to patients in control group
Control group
Active

Outcomes
Primary outcome [1] 262117 0
the prognosis of HCC patients treated by adefovir or not, defined by overall survival(OS) and disease free survival(DFS)
Timepoint [1] 262117 0
AFP,Ultrasound monthly and MRI or CT half a year for first 2 years post-surgery, then AFP,Ultrasound every 2 months and MRI or CT half a year up to 5 years post-surgery.HBV-DNA should be checked every 3 months.
Secondary outcome [1] 273194 0
the rate of HBV reactivation after liver resection and the change of liver function. The patients will check serum HBV-DNA every 3 months(in our hospital) and liver function every month(in the local hospital). If the HBV-DNA increases 10 times or become detectable, it means virus reactivation.
Timepoint [1] 273194 0
to check liver function monthly in the first 2 years and every 2 months after 2 years and HBV-DNA every 3 months after liver resection.

Eligibility
Key inclusion criteria
1.older than 16 years
2.HBsAg positive with HBV-DNA>=10000 copies/ml
3.histological diagnosis is HCC with chronic hepatitis in liver
4.Child A
5.tumor stage:BCLC A or B
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.company with HIV/HCV
2.received anti-virus treatment in 24 weeks before randomized assignment,including interferon/thymosin/NRTI
3.metastasis or with tumor thromboli in port vein
4.can't afford to taking adefovir
5.do not sign the information consent form

Study design
Purpose of the study
Treatment
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 then patients are allocated to each group according to the sequence generated by computer. This allocation is led by a researcher who is not involved in the trial.
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
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3193 0
China
State/province [1] 3193 0
Shanghai City

Funding & Sponsors
Funding source category [1] 267501 0
Hospital
Name [1] 267501 0
Eastern hepatobiliary hospital research fund for young doctor
Country [1] 267501 0
China
Primary sponsor type
Hospital
Name
Eastern hepatobiliary hospital
Address
Num. 225, Changhai Road, Yangpu District, Shanghai City, China. Post code:200438
Country
China
Secondary sponsor category [1] 257628 0
University
Name [1] 257628 0
Second military medical university
Address [1] 257628 0
NO. 800, Xiangyin Road, Yangpu District, Shanghai City, China. Post code:200433
Country [1] 257628 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269368 0
Ethics Committee of Eastern Hepato-biliary Surgical Hospital
Ethics committee address [1] 269368 0
NO.225, Changhai Road, Yangpu District, Shanghai city. Post code:200438
Ethics committee country [1] 269368 0
China
Date submitted for ethics approval [1] 269368 0
10/03/2007
Approval date [1] 269368 0
01/05/2007
Ethics approval number [1] 269368 0
EHPHKY2007-050

Summary
Brief summary
The purpose of our study is to see whether anti-virus drugs can improve the prognosis of liver cancer and reduce the viral reactivity. We supposed that adefovir can reduce the tumor recurrence and viral reactivity, prolong the overall survival of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32207 0
Address 32207 0
Country 32207 0
Phone 32207 0
Fax 32207 0
Email 32207 0
Contact person for public queries
Name 15454 0
Weiping Zhou
Address 15454 0
Num.225,Changhai Road, Yangpu District, Shanghai City, China, post code: 200438
Country 15454 0
China
Phone 15454 0
0086-021-81875521
Fax 15454 0
Email 15454 0
[email protected]
Contact person for scientific queries
Name 6382 0
Zhenguang Wang
Address 6382 0
Num.225,Changhai Road, Yangpu District, Shanghai City, China, post code: 200438
Country 6382 0
China
Phone 6382 0
0086-021-81875524
Fax 6382 0
Email 6382 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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