Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy
1 other identifier
observational
54
2 countries
27
Brief Summary
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2012
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2012
CompletedStudy Start
First participant enrolled
April 26, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2017
CompletedApril 24, 2017
April 1, 2017
4.9 years
March 20, 2012
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade
The proportion of participants with a confirmed increase in serum creatinine of at least one grade will be calculated as the number of participants with at least one grade increase in serum creatinine from baseline divided by the total number of subjects enrolled over the 4 years of accrual.
Baseline to Year 5
Secondary Outcomes (9)
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade evaluated using the competing risk cumulative incidence framework
Baseline to Year 5
Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min
Baseline to Year 5
Change in eGFR compared to eGFR at baseline by visit window
Baseline to Year 5
Proportion of participants who received appropriate dosing relative to renal function
Baseline to Year 5
Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event
Baseline to Year 5
- +4 more secondary outcomes
Study Arms (1)
Participants with chronic HBV infection
Participants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study.
Interventions
Subjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis.
Eligibility Criteria
Adult participants with chronic HBV infection receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy and with decompensated liver disease at time of consent.
You may qualify if:
- Estimated glomerular filtration rate (Cockcroft-Gault method)using actual body weight of ≥ 50 mL/min at time of entry into registry
- Negative serologies for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV)
- No history of solid organ or bone marrow transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (27)
Cedars-Sinai Medical Center for Liver Diseases and Transplantation
Los Angeles, California, 90048, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94304, United States
University of California at San Francisco Medical Center
San Francisco, California, 94143, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Florida Hospital Transplant
Orlando, Florida, 32804, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Alegent Creighton Health
Omaha, Nebraska, 68124, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor All Saints Medical Center
Fort Worth, Texas, 76104, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23249, United States
Harborview Medical Center
Seattle, Washington, 98195, United States
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z 2C7, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2012
First Posted
May 3, 2012
Study Start
April 26, 2012
Primary Completion
April 4, 2017
Study Completion
April 4, 2017
Last Updated
April 24, 2017
Record last verified: 2017-04