Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
1 other identifier
observational
420
1 country
1
Brief Summary
Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical resection. This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B patients after receiving RFA therapy for HCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
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
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedJanuary 5, 2011
January 1, 2011
January 3, 2011
January 4, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control
3 years
Secondary Outcomes (1)
HBV reactivation, incidence of ALT normalization, reduction of serum HBV DNA level, HBsAg loss and HBsAg seroconversion to anti-HBsAb, emergence of resistance.
3 years
Study Arms (1)
Entecavir
Interventions
Eligibility Criteria
chronic hepatitis B patients received RFA therapy for HCC
You may qualify if:
- HCC diagnosed by pathology verification or in accordance with the guidelines of American Association for the Study of Liver Diseases published in 2010 (typical vascular pattern in computed tomography scan or magnetic resonance imaging study) ,
- Solitary tumor less than 5 cm in diameter or 2-3 tumors with the largest one no more than 3 cm in diameter,
- No extrahepatic metastasis,
- No radiological evidence of invasion into major portal vein or hepatic vein branches,
- Good liver reserve with Child-Pugh Class A or B,
- A platelet count of more than 50,000/mm3,
- Serum creatinine level ≤ 2 mg/dL,
- No previous treatment for HCC,
- Positive for serum hepatitis B surface antigen (HBsAg) for more than 6 months
- Positive serum HBV DNA using a Cobas Amplicor HBV monitor (Roche Diagnostic System, Basel, Switzerland).
You may not qualify if:
- Dual or multiple infections with hepatitis C virus, hepatitis D virus, or the human immunodeficiency virus,
- Other forms of liver disease such as alcoholic hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis,
- Use of interferon alpha, thymosin or antiviral agents within 6 months preceding entry into the study,
- Women who are pregnant or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 5, 2011
Study Start
January 1, 2011
Last Updated
January 5, 2011
Record last verified: 2011-01