Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)

• Status: Active, not recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in China.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

Key Inclusion Criteria:

• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

• Adult males and non-pregnant, non-lactating females

• Documented evidence of chronic HBV infection

• HBeAg-positive, chronic hepatitis B with all of the following:

• HBeAg-positive at screening

• Screening HBV DNA ≥ 2 x 10^4 IU/mL

• Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN)

• Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced participants (defined as participants meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue)

• Previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit

• Adequate renal function

• Normal ECG

Key Exclusion Criteria:

• Females who are breastfeeding

• Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study

• Co-infection with hepatitis C virus, HIV, or hepatitis D virus

• Evidence of hepatocellular carcinoma

• Any history of, or current evidence of, clinical hepatic decompensation

• Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN

• Received solid organ or bone marrow transplant

• History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible

• Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion

• Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients

• Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance

• Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.