Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)
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ClinicalTrials.gov Identifier: NCT02836249 |
Recruitment Status :
Active, not recruiting
First Posted : July 18, 2016
Results First Posted : April 17, 2018
Last Update Posted : August 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HBV Chronic HBV Infections | Drug: TAF Drug: TDF Drug: TAF Placebo Drug: TDF Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 181 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg Positive, Chronic Hepatitis B |
Actual Study Start Date : | June 19, 2015 |
Actual Primary Completion Date : | December 15, 2016 |
Estimated Study Completion Date : | November 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: TAF
TAF + TDF placebo for up to 144 weeks
|
Drug: TAF
TAF 25 mg tablet administered orally once daily
Other Names:
Drug: TDF Placebo TDF placebo tablet administered orally once daily |
Active Comparator: TDF
TDF + TAF placebo for up to 144 weeks
|
Drug: TDF
TDF 300 mg tablet administered orally once daily
Other Name: Viread® Drug: TAF Placebo TAF placebo tablet administered orally once daily |
Experimental: Open-label TAF
All participants who complete the double-blind period will be eligible to receive open-label TAF until Week 384 of the study.
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Drug: TAF
TAF 25 mg tablet administered orally once daily
Other Names:
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- Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 [ Time Frame: Week 48 ]
- Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48 [ Time Frame: Week 48 ]
- Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline; Week 48 ]
- Percent Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
- Change From Baseline at Week 48 in Serum Creatinine [ Time Frame: Baseline; Week 48 ]
- Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48 [ Time Frame: Up to 48 weeks ]Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836249

Study Director: | Gilead Study Director | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02836249 |
Other Study ID Numbers: |
GS-US-320-0110 (China) 2013-000636-10 ( EudraCT Number ) |
First Posted: | July 18, 2016 Key Record Dates |
Results First Posted: | April 17, 2018 |
Last Update Posted: | August 18, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatitis Tenofovir Viread |
Hepatitis B Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Hepadnaviridae Infections DNA Virus Infections |