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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01270178
• Other study ID #: 20110103
• Status: Not yet recruiting
• Phase: N/A
• First received: January 3, 2011
• Last updated: January 4, 2011
• Start date: January 2011

Study information

• Verified date: January 2011
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chien-Wei Su, M.D.
• Phone: 02-28712121
• Email: cwsu2[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Entecavir
film coated tablets / 0.5mg / once daily / 3 years

Locations

Country	Name	City	State
Taiwan	Department of Medicine, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control		3 years	Yes
Secondary	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	Yes