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
Recruitment status was Not yet recruiting
Sponsor:
Taipei Veterans General Hospital,Taiwan
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
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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
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 May 21, 2013