Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
Documented evidence of chronic HBV infection prior to transplantation
Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
Liver Transplant ≥ 12 weeks prior to screening
Maintained on TDF alone or in combination with other approved antivirals for HBV prophylaxis or treatment
Have been on approved HBV oral antiviral (OAV) treatment for at least 12 weeks post-transplant prior to screening, with HBV DNA \< lower limit of quantification (LLOQ) at screening
Screening estimated glomerular filtration rate using the chronic kidney disease epidemiology collaboration (eGFR\_CKD-EPI) \< 90 ml/min/1.73m\^2
Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Women considered of child bearing potential must have a negative serum pregnancy test at Screening and a negative urine test at Baseline before dosing
Must be willing and able to comply with all study requirements
You may not be if
Multi-organ transplant that includes heart or lung recipient (participants who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll)
Participants with history of de novo or recurrent hepatocellular carcinoma (HCC) post-transplant and at screening
Histological evidence of unresolved transplant rejection
Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
Participants meeting any of the following laboratory parameters at screening:
* Alanine aminotransferase (ALT) \> 10 × the upper limit of normal (ULN)
* International normalized ratio (INR) \> 1.5 × ULN unless the participant is stable on anticoagulant regimen affecting INR
* Albumin \< 3.0 g/dL
* Direct bilirubin ≥ 4 × ULN
* Platelet count \< 50,000/mL
Co-infection with HIV or hepatitis C virus (HCV)
Recent (within 4 weeks of Screening) episode or infection requiring systemic antibiotics
Use of any prohibited medications listed within 28 days of the Baseline/Day 1 visit
Significant cardiovascular, pulmonary, or neurological disease
Use of investigational agents within 3 months of screening, unless allowed by the Sponsor
Use of any prohibited medications
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Known hypersensitivity to study drugs, metabolites or formulation excipients
Lactating females or those who may wish to become pregnant during the course of the study
Clareo Health | Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
