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Completed

NCT Number: NCT01590615

Registry Study for Patients With Chronic HBV Receiving Nucleotide 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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-HBV nucleoside/nucleotide therapy

Drug

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.

Primary outcomes

  1. Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade

    Time frame: Baseline to Year 5

    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 outcomes

  1. 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

  2. Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min

    Time frame: Baseline to Year 5

  3. Change in eGFR compared to eGFR at baseline by visit window

    Time frame: Baseline to Year 5

  4. Proportion of participants who received appropriate dosing relative to renal function

    Time frame: Baseline to Year 5

  5. 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

  6. 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

  7. Change in MELD score and liver disease status compared to MELD score at baseline by visit window

    Time frame: Baseline to Year 5

  8. Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL)

    Time frame: Baseline to Year 5

  9. The median number of renal related adverse events per participant over the evaluation period

    Time frame: Baseline to Year 5

    Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 3, 2012
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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