Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590615
• Other study ID #: GX-US-174-0172
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: April 20, 2017
• Start date: April 26, 2012
• Est. completion date: April 4, 2017

Study information

• Verified date: April 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Toronto Liver Centre	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Vancouver ID Research and Care Centre Society	Vancouver	British Columbia
United States	Emory University Hospital	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Baylor All Saints Medical Center	Fort Worth	Texas
United States	The Methodist Hospital	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Cedars-Sinai Medical Center for Liver Diseases and Transplantation	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	Methodist University Hospital	Memphis	Tennessee
United States	Jackson Memorial Hospital	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Alegent Creighton Health	Omaha	Nebraska
United States	Florida Hospital Transplant	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	Oregon Health and Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Saint Louis University Hospital	Saint Louis	Missouri
United States	University of California at San Francisco Medical Center	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Georgetown University Hospital	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min		Baseline to Year 5
Secondary	Change in eGFR compared to eGFR at baseline by visit window		Baseline to Year 5
Secondary	Proportion of participants who received appropriate dosing relative to renal function		Baseline to Year 5
Secondary	Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event		Baseline to Year 5
Secondary	Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline		Baseline to Year 5
Secondary	Change in MELD score and liver disease status compared to MELD score at baseline by visit window		Baseline to Year 5
Secondary	Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL)		Baseline to Year 5
Secondary	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