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Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose
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.

Condition Intervention
Liver Transplantation
Hepatitis B
Drug: lamivudine adefovir entecavir HBIG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lamivudine 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 and adefovir 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: entecavir 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01139203

Locations
China
Shanghai First People's Hospital
Shanghai, China, 200000
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Zhejiang University
Investigators
Study Chair: Zhi-Hai Peng, MD PHD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  More Information

Publications:
Responsible Party: Shanghai First People's Hosptial
ClinicalTrials.gov Identifier: NCT01139203     History of Changes
Other Study ID Numbers: SH20100601 
Study First Received: June 7, 2010
Last Updated: June 25, 2010
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
HBV recurrence
entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Lamivudine
Adefovir
Adefovir dipivoxil
Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on December 08, 2016