Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
NCT ID: NCT02979613
Last Updated: 2020-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
490 participants
INTERVENTIONAL
2016-12-29
2020-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAF 25 mg
Double-blind (DB) phase: TAF 25 mg + TDF placebo for up to 53 weeks. Open-label extension (OLE) phase: TAF 25 mg for up to 52 weeks.
TAF
25 mg tablet administered orally once daily
TDF Placebo
Tablet administered orally once daily
TDF 300 mg
DB phase: TDF 300 mg + TAF placebo for up to 50 weeks. OLE phase: TAF 25 mg for up to 52 weeks.
TAF
25 mg tablet administered orally once daily
TDF
300 mg tablet administered orally once daily
TAF Placebo
Tablet administered orally once daily
Interventions
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TAF
25 mg tablet administered orally once daily
TDF
300 mg tablet administered orally once daily
TAF Placebo
Tablet administered orally once daily
TDF Placebo
Tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult male and non-pregnant, non-lactating females
* Documented evidence of chronic hepatitis B virus (HBV) infection previously
* Maintained on tenofovir disoproxil fumarate (TDF) 300 mg once daily for at least 48 weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viral suppression (HBV DNA \< lower limit of quantitation) for a minimum of 12 weeks prior to screening
* Adequate renal function
* Normal Electrocardiogram
Exclusion Criteria
* 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 (HCV), hepatitis D virus (HDV), or human immunodeficiency virus (HIV)
* Evidence of hepatocellular carcinoma
* Current evidence of, or recent (≤ 5 year) history of clinical hepatic decompensation
* Abnormal hematological and biochemical parameters, including:
* Hemoglobin \< 10 g/dL
* Absolute neutrophil count \< 750/mm\^3
* Platelets ≤ 50,000/mm\^3
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 × upper limit of the normal (ULN)
* Albumin \< 3.0 mg/ dL
* International normalized ratio (INR) \> 1.5 × ULN (unless stable on anticoagulant regimen)
* Total bilirubin \> 2.5 × ULN
* Received solid organ or bone marrow transplant
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (eg, basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
* Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
* Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF 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 compliance
* Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
* Use of investigational agents within 3 months of screening, unless allowed by the sponsor
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Los Angeles, California, United States
Palo Alto, California, United States
Pasadena, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Novi, Michigan, United States
Flushing, New York, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Sugar Land, Texas, United States
Edmonton, , Canada
Toronto, , Canada
Vancouver, , Canada
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Milan, , Italy
Goyang, Gyeonggi-d, South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Majadahonda, , Spain
Chiayi City, , Taiwan
Kaohsiung City, , Taiwan
Taipei, , Taiwan
London, , United Kingdom
London, , United Kingdom
Countries
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References
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Lampertico P, Buti M, Fung S, Ahn SH, Chuang WL, Tak WY, Ramji A, Chen CY, Tam E, Bae H, Ma X, Flaherty JF, Gaggar A, Lau A, Liu Y, Wu G, Suri V, Tan SK, Subramanian GM, Trinh H, Yoon SK, Agarwal K, Lim YS, Chan HLY. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020 May;5(5):441-453. doi: 10.1016/S2468-1253(19)30421-2. Epub 2020 Feb 20.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003632-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-320-4018
Identifier Type: -
Identifier Source: org_study_id
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