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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01270178
First received: January 3, 2011
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

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 Intervention
Chronic Hepatitis B
Hepatocellular Carcinoma
Drug: Entecavir

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 420
Study Start Date: January 2011
Groups/Cohorts Assigned Interventions
Entecavir Drug: Entecavir
film coated tablets / 0.5mg / once daily / 3 years

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 3, 2011
Last Updated: January 4, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Carcinoma, Hepatocellular
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
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014