Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT00768157 |
Recruitment Status
: Unknown
Verified February 2009 by Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted
: October 7, 2008
Last Update Posted
: February 9, 2009
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Sponsor:
Sun Yat-sen University
Information provided by:
Sun Yat-sen University
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | October 6, 2008 | ||||||||||||
First Posted Date ICMJE | October 7, 2008 | ||||||||||||
Last Update Posted Date | February 9, 2009 | ||||||||||||
Study Start Date ICMJE | April 2007 | ||||||||||||
Estimated Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Overall survivals [ Time Frame: 2,3,5years ] | ||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00768157 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
Recurrence rate [ Time Frame: 2,3,5years ] | ||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma | ||||||||||||
Official Title ICMJE | Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma | ||||||||||||
Brief Summary | Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma. | ||||||||||||
Detailed Description | As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.To investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis B virus (HBV)-related hepatocellular carcinoma(HCC),we planed to conduct this clinical trial. | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 4 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Unknown status | ||||||||||||
Estimated Enrollment ICMJE |
200 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date | August 2010 | ||||||||||||
Estimated Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | China | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00768157 | ||||||||||||
Other Study ID Numbers ICMJE | SYSUCC-HCC004 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | Cancer Center of Sun Yat-sen University | ||||||||||||
Study Sponsor ICMJE | Sun Yat-sen University | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | Sun Yat-sen University | ||||||||||||
Verification Date | February 2009 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |