A randomized clinical trial of adefovir to treat patients with hepatitis B-related hepatocellular carcinoma after radical tumor resection

a randomized clinical trial to study whether adefovir can improve the prognosis of HCC patients with HBV-DNA>=10000 copies/ml

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000840987

Enrollment

200

Registered

2011-08-09

Start date

2007-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 70 Years

Healthy volunteers

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

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

Outcome results