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: March 4, 2014
Last verified: March 2014

March 20, 2012
March 4, 2014
April 2012
December 2016   (final data collection date for primary outcome measure)
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.
The risk of confirmed increase in serum creatinine from baseline of at least one grade over the registry evaluation period. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01590615 on ClinicalTrials.gov Archive Site
  • 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.
  • The change from baseline in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault (C-G) method over the registry evaluation period. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients with confirmed eGFR below 50 mL/min. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients receiving appropriate dosing relative to renal function. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients who discontinue nucleotide/side therapy due to a renal-related event(s). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients with ALT normalization (≤ 1 x ULN). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients with change in MELD score and liver disease status compared to baseline. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients with plasma HBV DNA < 400 copies/mL (69 IU/mL). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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. Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
5 Years
Not Provided
Non-Probability Sample

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.

Hepatitis B
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.
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.
Intervention: Drug: Anti-HBV nucleoside/nucleotide therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
July 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01590615
GX-US-174-0172
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: John F. Flaherty, Jr, PharmD Gilead Sciences
Gilead Sciences
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP