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Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Zhejiang University
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01139203
First received: June 7, 2010
Last updated: June 25, 2010
Last verified: August 2009
History of Changes

June 7, 2010
June 25, 2010
August 2009
December 2012   (final data collection date for primary outcome measure)
serological markers of HBV [ Time Frame: every three month after liver transplantation ] [ Designated as safety issue: No ]
Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.
Same as current
Complete list of historical versions of study NCT01139203 on ClinicalTrials.gov Archive Site
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Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
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Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Liver Transplantation
  • Hepatitis B
Drug: lamivudine adefovir entecavir HBIG
lamivudine 100mg orally daily adefovir 10mg orally daily entecavir 0.5mg orally daily HBIG 2000 unit intravenously during the anhepatic phase,and followed 800 unit intramuscularly daily until day 14,then 400 unit intramuscularly twice weekly
  • Active Comparator: lamivudine
    Intervention: Drug: lamivudine adefovir entecavir HBIG
  • Active Comparator: lamivudine and adefovir
    Intervention: Drug: lamivudine adefovir entecavir HBIG
  • Active Comparator: entecavir
    Intervention: Drug: lamivudine adefovir entecavir HBIG

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. patients into the transplant waiting list with HBV-related liver disease.
  2. HBsAg-positive.
  3. serum HBV-DNA negative.
  4. no HCV, HDV and HIV co-infection.
  5. without renal dysfunction.
  6. No lamivudine, adefovir and entecavir drug allergy history.
  7. no HBV-YMDD mutation for patients who have a long-term use of lamivudine.

Exclusion Criteria:

  1. patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
  2. HBsAg-negative.
  3. serum HBV-DNA positive.
  4. HCV, HDV and HIV co-infection.
  5. patients with severe renal dysfunction or failure.
  6. lamivudine, adefovir and entecavir drug allergy history.
  7. HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Both
18 Years to 65 Years
No
Contact: Zhi-Hai Peng, MD PHD 0086-021-63240090 ext 3132 pengpzh@hotmail.com
Contact: Tao Li, MD 0086-021-63240090 ext 3136 transplant@126.com
China
 
NCT01139203
SH20100601
Not Provided
Shanghai First People's Hosptial
Shanghai Jiao Tong University School of Medicine
Zhejiang University
Study Chair: Zhi-Hai Peng, MD PHD Shanghai First People's Hospital
Shanghai Jiao Tong University School of Medicine
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP