Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Partic… (NCT01940471) | Clinical Trial Compass
CompletedPhase 3
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
United States875 participantsStarted 2013-09-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 electrocardiogram (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, human immunodeficiency virus (HIV), or hepatitis D virus.
* Evidence of hepatocellular carcinoma .
* Any history of, or current evidence of, clinical hepatic decom…
What they're measuring
1
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48