Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01590615
First received: March 20, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This registry will remain open for approximately 5 years. Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.


Condition Intervention
Hepatitis B
Drug: Anti-HBV nucleoside/nucleotide therapy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Change in eGFR compared to eGFR at baseline by visit window [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Proportion of participants who received appropriate dosing relative to renal function [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Change in MELD score and liver disease status compared to MELD score at baseline by visit window [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL) [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • The median number of renal related adverse events per participant over the evaluation period [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
    Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term.


Estimated Enrollment: 400
Study Start Date: April 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusions:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590615

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

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01590615     History of Changes
Other Study ID Numbers: GX-US-174-0172
Study First Received: March 20, 2012
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Gilead Sciences:
Hepatitis
Hepatitis B
HBV
OLT
MELD
Renal Safety
Liver Transplant

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 28, 2014