Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
- Conditions
- Hepatitis B
- Interventions
- Drug: Anti-HBV nucleoside/nucleotide therapy
- Registration Number
- NCT01590615
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- Currently receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy within 6 months of inclusion into registry
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with chronic HBV infection Anti-HBV nucleoside/nucleotide therapy 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.
- Primary Outcome Measures
Name Time Method Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade Baseline to Year 5 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.
- Secondary Outcome Measures
Name Time Method 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 Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline Baseline to Year 5 Change in MELD score and liver disease status compared to MELD score at baseline by visit window Baseline to Year 5 Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL) Baseline to Year 5 The median number of renal related adverse events per participant over the evaluation period Baseline to Year 5 Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term.
Trial Locations
- Locations (27)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Stanford University
🇺🇸Palo Alto, California, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Florida Hospital Transplant
🇺🇸Orlando, Florida, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Vancouver ID Research and Care Centre Society
🇨🇦Vancouver, British Columbia, Canada
Cedars-Sinai Medical Center for Liver Diseases and Transplantation
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of California at San Francisco Medical Center
🇺🇸San Francisco, California, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Georgetown University Hospital
🇺🇸Washington, D.C., District of Columbia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Alegent Creighton Health
🇺🇸Omaha, Nebraska, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Baylor All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States