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: April 14, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590615

  Show 29 Study Locations
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: April 14, 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 April 15, 2014