Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
NCT ID: NCT02579382
Last Updated: 2020-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2015-11-10
2019-05-03
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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TDF + placebo
Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
TDF
300 mg tablets administered orally once daily
Placebo
Placebo administered orally once a week (every 7 days) for 12 doses
TDF + Vesatolimod 1 mg
Main Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
TDF
300 mg tablets administered orally once daily
Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
TDF + Vesatolimod 2 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
TDF
300 mg tablets administered orally once daily
Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
TDF + Vesatolimod 4 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
TDF
300 mg tablets administered orally once daily
Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
Interventions
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TDF
300 mg tablets administered orally once daily
Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
Placebo
Placebo administered orally once a week (every 7 days) for 12 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis B virus (HBV) infection
* HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening
Exclusion Criteria
* Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV)
* Chronic liver disease other than HBV
* Lactating or pregnant females or those that wish to become pregnant during the course of the study
18 Years
65 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
San Diego, California, United States
San Francisco, California, United States
Honolulu, Hawaii, United States
Catonsville, Maryland, United States
Boston, Massachusetts, United States
Flushing, New York, United States
Philadelphia, Pennsylvania, United States
Toronto, Ontario, Canada
Kowloon, , Hong Kong
Bologna, , Italy
Milan, , Italy
Pisa, , Italy
San Giovanni Rotondo, , Italy
Grafton, Auckland, New Zealand
Daegu, , South Korea
Seoul, , South Korea
Dalin, , Taiwan
Kaohsiung City, , Taiwan
London, , United Kingdom
Countries
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References
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Agarwal K, Ahn SH, Elkhashab M, Lau AH, Gaggar A, Bulusu A, Tian X, Cathcart AL, Woo J, Subramanian GM, Andreone P, Kim HJ, Chuang WL, Nguyen MH. Safety and efficacy of vesatolimod (GS-9620) in patients with chronic hepatitis B who are not currently on antiviral treatment. J Viral Hepat. 2018 Nov;25(11):1331-1340. doi: 10.1111/jvh.12942. Epub 2018 Aug 22.
Younossi ZM, Stepanova M, Janssen H, Agarwal K, Nguyen MH, Gane EJ, et al. The impact of treatment of chronic hepatitis B (CHB) on patient reported outcomes (PROs). Poster 1924. AASLD 2017. Hepatology; 66:1020A, 2017.
Lau A, Joshi A, Nguyen AH, Gaggar A, Patterson SD, Woo J. Peripheral blood immune cell profiling in virally suppressed chronic hepatitis B (CHB) patients and CHB patients not on an oral antiviral therapy. HBV International Meeting 2017.
Other Identifiers
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2015-002017-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-283-1062
Identifier Type: -
Identifier Source: org_study_id
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