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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
  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:

U.S. FDA Resources

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139203

Contacts
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

Locations
China
Shanghai First People's Hospital Recruiting
Shanghai, China, 200000
Contact: Zhi-Hai Peng, MD PHD     0086-021-63240090 ext 3132     pengpzh@hotmail.com    
Sub-Investigator: Tao Li, MD            
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Zhejiang University
Investigators
Study Chair: Zhi-Hai Peng, MD PHD Shanghai First People's Hospital
  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 A
Hepatitis B
Recurrence
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Disease Attributes
Pathologic Processes
 Adefovir
Adefovir dipivoxil
Lamivudine
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013