For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  2. Adult males and non-pregnant, non-lactating females
  3. Documented evidence of chronic HBV infection
  4. HBeAg-positive, chronic hepatitis B with all of the following:
  5. HBeAg-positive at screening
  6. Screening HBV DNA ≥ 2 x 10^4 IU/mL
  7. 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)
  8. 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)
  9. Previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit
  10. Adequate renal function
  11. Normal ECG Key

EXCLUSION CRITERIA

  1. Females who are breastfeeding
  2. Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study
  3. Co-infection with hepatitis C virus, HIV, or hepatitis D virus
  4. Evidence of hepatocellular carcinoma
  5. Any history of, or current evidence of, clinical hepatic decompensation
  6. Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN
  7. Received solid organ or bone marrow transplant
  8. 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
  9. Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
  10. 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
  11. Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
  12. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
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Study’s details


Contition

Chronic HBV Infection,Chronic HBV Infections,HBV

Age

18+

Phase

Phase 3

Participants needed

875

Est. Completion Date

Nov 2023

Treatment type

Interventional


Sponsor

Gilead Sciences

ClinicalTrials.gov identifier

NCT01940471

Study number

GS-US-320-0110

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