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Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy


N/A
20 Years
N/A
Not Enrolling
Both
Chronic Hepatitis B, Hepatocellular Carcinoma

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Trial Information

Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy


Inclusion Criteria:



- 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).

Exclusion Criteria:

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control

Outcome Time Frame:

3 years

Safety Issue:

Yes

Authority:

Taiwan: Institutional Review Board

Study ID:

20110103

NCT ID:

NCT01270178

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Chronic Hepatitis B
  • Hepatocellular Carcinoma
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Hepatitis, Chronic
  • Hepatitis B, Chronic
  • Carcinoma, Hepatocellular

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