- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00059267
Prevention of Recurrent Hepatitis B After Liver Transplantation
October 16, 2017 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis B accounts for approximately 5000 deaths per year in the United States.
Liver transplantation offers the only hope for patients who develop end-stage liver disease.
Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%.
Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival.
However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance.
Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear.
Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage.
Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant.
Thus, it may be possible to tailor the preventive therapy according to the risk.
The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
317
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients listed for liver or combined liver-kidney transplantation for hepatitis B including hepatitis B cirrhosis, hepatitis B liver cancer and fulminant hepatitis B.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anna S Lok, MD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2001
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
April 22, 2003
First Submitted That Met QC Criteria
April 22, 2003
First Posted (Estimate)
April 23, 2003
Study Record Updates
Last Update Posted (Actual)
October 18, 2017
Last Update Submitted That Met QC Criteria
October 16, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Hepatic Insufficiency
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Liver Failure
- Hepatitis B
- Hepatitis
- Hepatitis A
- Liver Failure, Acute
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Adefovir dipivoxil
Other Study ID Numbers
- NIH HBV-OLT (completed)
- U01DK057577 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Ain Shams UniversityCompleted
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
-
Mahidol UniversityUnknownChronic Hepatitis B, HBsAg, Hepatitis B VaccineThailand
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.Unknown
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingChronic Hepatitis b | Cirrhosis Due to Hepatitis BChina
-
Tongji HospitalGilead SciencesRecruiting
Clinical Trials on HBIG, Epivir, Hepsera
-
Bristol-Myers SquibbCompletedHepatitis B, ChronicAustralia, Korea, Republic of, Taiwan, Thailand, Hong Kong, United States, Poland, Greece, Canada, Singapore, Philippines, Brazil, India, Indonesia, Italy, Malaysia, Russian Federation, Turkey
-
Green Cross CorporationUnknownHepatitis B InfectionKorea, Republic of
-
Third Affiliated Hospital, Sun Yat-Sen UniversityUnknownLiver Transplantation | Hepatitis BChina
-
University of WashingtonGlaxoSmithKline; Gilead SciencesCompletedHepatitis BUnited States
-
Govind Ballabh Pant HospitalIndian Council of Medical Research; Lady Hardinge Medical CollegeCompleted
-
BiotestAMS Advanced Medical Services GmbHCompletedHepatitis BSpain, United Kingdom, France, Italy
-
Health Science Center of Xi'an Jiaotong UniversityCompleted
-
Beijing Ditan HospitalUnknown
-
GlaxoSmithKlineCompleted
-
Yonsei UniversityBristol-Myers Squibb; Chonbuk National University Hospital; Seoul St. Mary's... and other collaboratorsUnknownChronic Hepatitis B