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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: Anti-HBV nucleoside/nucleotide therapy

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver ID Research and Care Centre Society
  • Ontario
    • Toronto, Ontario, Canada, M6H 3M1
      • Toronto Liver Centre
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center for Liver Diseases and Transplantation
    • Palo Alto, California, United States, 94304
      • Stanford University
    • San Francisco, California, United States, 94143
      • University of California at San Francisco Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
    • Orlando, Florida, United States, 32804
      • Florida Hospital Transplant
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Alegent Creighton Health
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Anti-HBV nucleoside/nucleotide therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term.	Baseline to Year 5

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2012
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Hepatitis; Hepatitis B; HBV; Liver Transplant; MELD; OLT; Renal Safety
• Additional Relevant MeSH Terms: Digestive System Diseases; 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; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: GX-US-174-0172

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No