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

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ClinicalTrials.gov Identifier: NCT01270178
Recruitment Status : Unknown
Verified January 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Not yet recruiting
First Posted : January 5, 2011
Last Update Posted : January 5, 2011
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Chronic Hepatitis B Hepatocellular Carcinoma Drug: Entecavir

Study Design

Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
Study Start Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Entecavir Drug: Entecavir
film coated tablets / 0.5mg / once daily / 3 years


Outcome Measures

Primary Outcome Measures :
  1. The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. HBV reactivation, incidence of ALT normalization, reduction of serum HBV DNA level, HBsAg loss and HBsAg seroconversion to anti-HBsAb, emergence of resistance. [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
chronic hepatitis B patients received RFA therapy for HCC
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270178


Contacts
Contact: Chien-Wei Su, M.D. 02-28712121 ext 2049 cwsu2@vghtpe.gov.tw

Locations
Taiwan
Department of Medicine, Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan
Contact: Chien-Wei Su, M.D.    02-28712121 ext 2049    cwsu2@vghtpe.gov.tw   
Principal Investigator: Jaw-Ching Wu, M.D. Ph.D.         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
More Information

Responsible Party: Jaw-Ching Wu, M.D. Ph.D/ Attending Physician, Department of Medical Research and Education, Veterans General Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier: NCT01270178     History of Changes
Other Study ID Numbers: 20110103
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis, Chronic
Carcinoma, Hepatocellular
Hepatitis B
Hepatitis B, Chronic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents