Clinical trial NCT01590615: Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
Official title: Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: Hepatitis
Hepatitis B
HBV
OLT
MELD
Renal Safety
Liver Transplant
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Key Inclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade
timeFrame: Baseline to Year 5
Secondary outcomes:
measure: 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
timeFrame: Baseline to Year 5
measure: Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min
timeFrame: Baseline to Year 5
measure: Change in eGFR compared to eGFR at baseline by visit window
timeFrame: Baseline to Year 5
measure: Proportion of participants who received appropriate dosing relative to renal function
timeFrame: Baseline to Year 5
measure: Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event
timeFrame: Baseline to Year 5
measure: Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline
timeFrame: Baseline to Year 5
measure: Change in MELD score and liver disease status compared to MELD score at baseline by visit window
timeFrame: Baseline to Year 5
measure: Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL)
timeFrame: Baseline to Year 5
measure: The median number of renal related adverse events per participant over the evaluation period
timeFrame: Baseline to Year 5
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center for Liver Diseases and Transplantation
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington, D.C.
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Transplant
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Omaha
country: United States
facility: Alegent Creighton Health
state: Nebraska
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: