Clinical trial NCT02579382: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: HBV
Hepatitis
Liver Disease
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-10-19
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
timeFrame: Baseline; Week 24
Secondary outcomes:
measure: Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
timeFrame: Week 24
measure: Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
timeFrame: Week 24
measure: Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
timeFrame: Week 48
measure: Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
timeFrame: Baseline; Week 12
measure: Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
timeFrame: Baseline; Week 48
measure: Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
timeFrame: Baseline to Week 48
measure: Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
timeFrame: Week 24
measure: Percentage of Participants With HBV DNA < LLOQ at Week 48
timeFrame: Week 48
measure: Percentage of Participants Experiencing Virologic Breakthrough
timeFrame: Weeks 24 and 48
measure: Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
timeFrame: Baseline; Week 48
measure: Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: AUCinf of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: %AUCexp of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: Cmax of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: Clast of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: Tmax of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: Tlast of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: T1/2 of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
measure: PK Parameter: CL/F of Vesatolimod
timeFrame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Honolulu
country: United States
state: Hawaii
city: Catonsville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Flushing
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Toronto
country: Canada
state: Ontario
city: Kowloon
country: Hong Kong
city: Bologna
country: Italy
city: Milano
country: Italy
city: Pisa
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Grafton
country: New Zealand
state: Auckland
city: Dalin
country: Taiwan
city: Kaohsiung
country: Taiwan
city: London
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.