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COMPLETEDPHASE2

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

A Phase 2, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Subjects With Chronic HBV Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

NCT02862548•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+9 more criteria

Locations (1)

Auckland City Hospital

Auckland, New Zealand

Key Dates

Start Date

September 16, 2016

Primary Completion Date

February 8, 2018

Completion Date

May 5, 2021

Last Updated

June 8, 2022

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

TAF

DRUG

TDF

DRUG

Other approved antivirals

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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