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
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
2 other identifiers
interventional
192
8 countries
21
Brief Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2015
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedStudy Start
First participant enrolled
November 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2019
CompletedResults Posted
Study results publicly available
May 18, 2020
CompletedMay 18, 2020
May 1, 2020
1.2 years
October 15, 2015
May 1, 2020
May 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (\> 19 vs ≤ 19 IU/L for females; \> 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
Baseline; Week 24
Secondary Outcomes (22)
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Week 24
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Week 48
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
Week 24
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
Week 48
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
Baseline; Week 12
- +17 more secondary outcomes
Study Arms (4)
TDF + placebo
PLACEBO COMPARATORMain 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 + Vesatolimod 1 mg
EXPERIMENTALMain 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 + Vesatolimod 2 mg
EXPERIMENTALMain 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 + Vesatolimod 4 mg
EXPERIMENTALMain 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.
Interventions
300 mg tablets administered orally once daily
Tablets administered orally once a week (every 7 days) for 12 doses
Eligibility Criteria
You may qualify if:
- Adult males or females between the ages of 18-65
- Chronic hepatitis B virus (HBV) infection
- HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening
You may not qualify if:
- Extensive bridging fibrosis or cirrhosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (21)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Palo Alto, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Catonsville, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Flushing, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Kowloon, Hong Kong
Unknown Facility
Bologna, Italy
Unknown Facility
Milan, Italy
Unknown Facility
Pisa, Italy
Unknown Facility
San Giovanni Rotondo, Italy
Unknown Facility
Grafton, Auckland, New Zealand
Unknown Facility
Daegu, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Dalin, Taiwan
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
London, United Kingdom
Related Publications (3)
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.
PMID: 29851204RESULTYounossi 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.
RESULTLau 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2015
First Posted
October 19, 2015
Study Start
November 10, 2015
Primary Completion
January 16, 2017
Study Completion
May 3, 2019
Last Updated
May 18, 2020
Results First Posted
May 18, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share