Study to Evaluate the Safety, Tolerability, and Efficacy... | NCT02579382 | Trialant
NCT02579382
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
May 18, 2020Actual
Enrollment
192Actual
Phase
Phase 2
Conditions
Chronic Hepatitis B
Interventions
TDF
Vesatolimod
Placebo
Countries
United States
Canada
Hong Kong
Italy
New Zealand
South Korea
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02579382
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-283-1062
Secondary IDs
ID
Type
Description
Link
2015-002017-30
EudraCT Number
Brief Title
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
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 10, 2015Actual
Primary Completion Date
Jan 16, 2017Actual
Completion Date
May 3, 2019Actual
First Submitted Date
Oct 15, 2015
First Submission Date that Met QC Criteria
Oct 16, 2015
First Posted Date
Oct 19, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 1, 2020
Results First Submitted that Met QC Criteria
May 1, 2020
Results First Posted Date
May 18, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 4, 2017
Certification/Extension First Submitted that Passed QC Review
Dec 4, 2017
Certification/Extension First Posted Date
Dec 7, 2017Actual
Last Update Submitted Date
May 1, 2020
Last Update Posted Date
May 18, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis B
Keywords
HBV
Hepatitis
Liver Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
192Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TDF + placebo
Placebo Comparator
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.
Drug: TDF
Drug: Placebo
TDF + Vesatolimod 1 mg
Experimental
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.
Drug: TDF
Drug: Vesatolimod
TDF + Vesatolimod 2 mg
Experimental
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.
Drug: TDF
Drug: Vesatolimod
TDF + Vesatolimod 4 mg
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TDF
Drug
300 mg tablets administered orally once daily
TDF + Vesatolimod 1 mg
TDF + Vesatolimod 2 mg
TDF + Vesatolimod 4 mg
TDF + placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative Hepatitis B Envelope Antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Other Outcomes
Not provided
Eligibility Module
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.
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.
Result
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.
Result
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
260 participants were screened
Recruitment Details
Participants were enrolled at study sites in Asia, Europe, New Zealand, and North America. The first participant was screened on 10 November 2015. The last study visit occurred on 03 May 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
Periods
Title
Milestones
Reasons Not Completed
Main Study Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: TDF
Drug: Vesatolimod
Viread®
Vesatolimod
Drug
Tablets administered orally once a week (every 7 days) for 12 doses
TDF + Vesatolimod 1 mg
TDF + Vesatolimod 2 mg
TDF + Vesatolimod 4 mg
GS-9620
Placebo
Drug
Placebo administered orally once a week (every 7 days) for 12 doses
TDF + placebo
Week 24
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Week 48
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative Hepatitis B Surface Antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Week 24
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Week 48
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
Baseline; Week 12
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
Baseline; Week 48
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Baseline to Week 12
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 24 post-baseline visit.
Baseline to Week 24
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Baseline to Week 48
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Week 24
Percentage of Participants With HBV DNA < LLOQ at Week 48
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Week 48
Percentage of Participants Experiencing Virologic Breakthrough
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having had HBV DNA < 69 IU/mL or confirmed 1.0 log10 IU/mL or greater increase in HBV DNA from nadir. Confirmation requires 2 consecutive occurrences of elevation in HBV DNA to > 69 IU/mL after having had HBV DNA < 69 IU/mL or 1.0 log10 IU/mL or greater increases in HBV DNA from nadir.
Weeks 24 and 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
Sequence analysis of the HBV pol/RT was attempted for any participant who had HBV DNA ≥ 69 IU/mL at Week 48 or early discontinuation. Results of the alignment of Week 48 and baseline sequence were reported as a change from baseline sequence.
Baseline; Week 48
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
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.
FG002
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.
FG003
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.
FG00028 subjects
FG00153 subjects
FG00256 subjects
FG00355 subjects
COMPLETED
FG00028 subjects
FG00153 subjects
FG00254 subjects
FG00352 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Optional Treatment Extension Phase(OTEP)
Type
Comment
Milestone Data
STARTED
FG00027 subjects1 participant who completed the Main Study Phase did not enter the OTEP.
FG00151 subjects2 participants who completed the Main Study Phase did not enter the OTEP.
FG00254 subjects
FG00349 subjects3 participants who completed the Main Study Phase did not enter the OTEP.
COMPLETED
FG00026 subjects
FG00144 subjects
FG00250 subjects
FG00344 subjects
NOT COMPLETED
FG0001 subjects
FG0017 subjects
FG0024 subjects
FG0035 subjects
Type
Comment
Reasons
Withdrew Consent
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG003
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TDF + Placebo
Main Study Phase: 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.
BG001
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.
BG002
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.
BG003
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.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG00153
BG00256
BG00355
BG004192
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041± 10.4
BG00141± 9.6
BG00244± 10.3
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00121
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
Asian
BG00022
BG00141
BG002
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of race or ethnicity information.
Count of Participants
Participants
No
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG0000
BG0010
Region of Enrollment
Number
participants
Title
Denominators
Categories
New Zealand
Title
Measurements
BG0001
BG0010
BG002
Serum Hepatitis B Surface Antigen (HBsAg) (log10 IU/mL)
Mean
Standard Deviation
log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0003.8± 0.84
BG0013.7± 0.84
BG002
Hepatitis B Envelope Antigen (HBeAg) Status
Count of Participants
Participants
Title
Denominators
Categories
HBeAg Status- Negative
Title
Measurements
BG00017
BG00133
BG002
Hepatitis B Virus (HBV) DNA
Mean
Standard Deviation
log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0005.9± 2.10
BG0015.9± 1.80
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
The Full Analysis Set included all participants who were randomized and took at least 1 dose of study drug.
Posted
Least Squares Mean
95% Confidence Interval
log10 IU/mL
Baseline; Week 24
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + Placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00028
OG00153
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.163(-0.305 to -0.022)
OG001-0.056(-0.159 to 0.047)
OG002-0.146(-0.246 to -0.045)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
MMRM
0.227
MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
Least Squares Mean Difference
0.107
2-Sided
95
-0.067
0.282
Superiority
OG000
OG002
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative Hepatitis B Envelope Antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
Secondary
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative Hepatitis B Surface Antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Participants in the Full Analysis Set who were HBsAg positive at baseline were analyzed.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
Secondary
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Participants in the Full Analysis Set who were HBsAg positive at baseline were analyzed.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
Secondary
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 12
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
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.
Secondary
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 48
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
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.
Secondary
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Participants in the Full Analysis Set were analyzed.
Posted
Number
percentage of participants
Baseline to Week 12
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
TDF + Vesatolimod 4 mg
Secondary
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 24 post-baseline visit.
Participants in the Full Analysis Set were analyzed.
Posted
Number
percentage of participants
Baseline to Week 24
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
TDF + Vesatolimod 4 mg
Secondary
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Participants in the Full Analysis Set were analyzed.
Posted
Number
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
TDF + Vesatolimod 4 mg
Secondary
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Participants in the Full Analysis Set were analyzed.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
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.
Secondary
Percentage of Participants With HBV DNA < LLOQ at Week 48
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Participants in the Full Analysis Set were analyzed.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
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.
Secondary
Percentage of Participants Experiencing Virologic Breakthrough
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having had HBV DNA < 69 IU/mL or confirmed 1.0 log10 IU/mL or greater increase in HBV DNA from nadir. Confirmation requires 2 consecutive occurrences of elevation in HBV DNA to > 69 IU/mL after having had HBV DNA < 69 IU/mL or 1.0 log10 IU/mL or greater increases in HBV DNA from nadir.
Participants in the Full Analysis Set were analyzed.
Posted
Number
percentage of participants
Weeks 24 and 48
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
Secondary
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
Sequence analysis of the HBV pol/RT was attempted for any participant who had HBV DNA ≥ 69 IU/mL at Week 48 or early discontinuation. Results of the alignment of Week 48 and baseline sequence were reported as a change from baseline sequence.
Participants in the Full Analysis Set with available data were analyzed.
Posted
Count of Participants
Participants
No
Baseline; Week 48
ID
Title
Description
OG000
TDF + Placebo
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
OG001
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.
OG002
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.
OG003
Secondary
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
The PK Substudy Analysis Set included all randomized participants who took at least 1 dose of vesatolimod, participated in the PK substudy, and had at least 1 non-missing steady state PK parameter.
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.
OG001
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.
OG002
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.
Units
Counts
Time Frame
First dose date up to last dose of study drug (Maximum: 144 weeks)
Description
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
0
28
0
28
14
28
EG001
TDF + Vesatolimod 1 mg
Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod (GS 9620) 1 mg tablet orally once a week (every 7 days) for 12 doses.
0
53
1
53
25
53
EG002
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.
0
56
1
56
27
56
EG003
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.
0
55
1
55
33
55
EG004
TDF Extension From TDF + Placebo
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; Includes participants who received TDF + Placebo in the Main Study Phase.
0
27
1
27
7
27
EG005
TDF Extension From TDF + Vesatolimod 1 mg
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 1 mg in the Main Study Phase.
0
51
4
51
14
51
EG006
TDF Extension From TDF + Vesatolimod 2 mg
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 2 mg in the Main Study Phase.
0
54
5
54
13
54
EG007
TDF Extension From TDF + Vesatolimod 4 mg
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144; includes participants who received TDF + Vesatolimod 4 mg in the Main Study Phase.
0
49
1
49
12
49
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG0031 affected55 at risk
EG0040 affected27 at risk
EG0050 affected51 at risk
EG0060 affected54 at risk
EG0070 affected49 at risk
Large intestine polyp
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Chest pain
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Pyrexia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected53 at risk
EG0020 affected56 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Pelvic congestion
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected53 at risk
EG0021 affected56 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0002 affected28 at risk
EG0013 affected53 at risk
EG0021 affected56 at risk
EG0031 affected55 at risk
EG0040 affected27 at risk
EG0050 affected51 at risk
EG0060 affected54 at risk
EG0072 affected49 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0002 affected28 at risk
EG0013 affected53 at risk
EG0021 affected56 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0014 affected53 at risk
EG0022 affected56 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected53 at risk
EG0023 affected56 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0003 affected28 at risk
EG0015 affected53 at risk
EG0023 affected56 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected53 at risk
EG0020 affected56 at risk
EG003
Asthenia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected53 at risk
EG0022 affected56 at risk
EG003
Chills
General disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected53 at risk
EG0026 affected56 at risk
EG003
Fatigue
General disorders
MedDRA (22.0)
Systematic Assessment
EG0006 affected28 at risk
EG0018 affected53 at risk
EG0026 affected56 at risk
EG003
Influenza like illness
General disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected53 at risk
EG0020 affected56 at risk
EG003
Pyrexia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected28 at risk
EG0014 affected53 at risk
EG0025 affected56 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected53 at risk
EG0020 affected56 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0003 affected28 at risk
EG0012 affected53 at risk
EG0022 affected56 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0003 affected28 at risk
EG0013 affected53 at risk
EG0020 affected56 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected53 at risk
EG0023 affected56 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected53 at risk
EG0023 affected56 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected53 at risk
EG0024 affected56 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0003 affected28 at risk
EG0015 affected53 at risk
EG0024 affected56 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected53 at risk
EG0023 affected56 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0003 affected28 at risk
EG0013 affected53 at risk
EG0021 affected56 at risk
EG003
Headache
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0005 affected28 at risk
EG0014 affected53 at risk
EG00210 affected56 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected53 at risk
EG0020 affected56 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected28 at risk
EG0015 affected53 at risk
EG0021 affected56 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected53 at risk
EG0021 affected56 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Point of Contact
Title
Organization
Phone
Extension
Email
Gilead Clinical Study Information Center
Gilead Sciences
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
ID
Term
D019694
Hepatitis B, Chronic
D006505
Hepatitis
D008107
Liver Diseases
Ancestor Terms
ID
Term
D006509
Hepatitis B
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D018347
Hepadnaviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D006525
Hepatitis, Viral, Human
D006521
Hepatitis, Chronic
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068698
Tenofovir
C582524
vesatolimod
Ancestor Terms
ID
Term
D063065
Organophosphonates
D009943
Organophosphorus Compounds
D009930
Organic Chemicals
D000225
Adenine
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
Investigator's discretion
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Non-compliance with Study Drug
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
44
± 10.3
BG00442± 10.1
16
BG00320
BG00469
Male
BG00016
BG00132
BG00240
BG00335
BG004123
48
BG00344
BG004155
White
BG0004
BG0016
BG0025
BG00310
BG00425
Black or African American
BG0001
BG0015
BG0023
BG0030
BG0049
Native Hawaiian or Pacific Islander
BG0001
BG0010
BG0020
BG0031
BG0042
Other
BG0000
BG0011
BG0020
BG0030
BG0041
BG002
0
BG0030
BG0040
Not Hispanic or Latino
BG00028
BG00153
BG00256
BG00355
BG004192
Not Permitted
BG0000
BG0010
BG0020
BG0030
BG0040
1
BG0033
BG0045
Canada
Title
Measurements
BG0002
BG0018
BG0029
BG0034
BG00423
South Korea
Title
Measurements
BG0007
BG00112
BG00217
BG00315
BG00451
Hong Kong
Title
Measurements
BG0000
BG0013
BG0020
BG0032
BG0045
United States
Title
Measurements
BG0006
BG00114
BG00213
BG00310
BG00443
Taiwan
Title
Measurements
BG0005
BG0014
BG0026
BG0036
BG00421
Italy
Title
Measurements
BG0006
BG0018
BG0026
BG00312
BG00432
United Kingdom
Title
Measurements
BG0001
BG0014
BG0024
BG0033
BG00412
3.5
± 0.88
BG0033.6± 0.74
BG0043.6± 0.82
33
BG00334
BG004117
HBeAg Status- Positive
Title
Measurements
BG00011
BG00120
BG00223
BG00321
BG00475
5.6
± 1.85
BG0035.9± 1.70
BG0045.8± 1.82
54
-0.036
(-0.138 to 0.065)
MMRM
0.840
MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
Least Squares Mean Difference
0.018
2-Sided
95
-0.156
0.191
Superiority
OG000
OG003
MMRM
0.151
MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
Least Squares Mean Difference
0.127
2-Sided
95
-0.047
0.301
Superiority
OG003
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.
Units
Counts
Participants
OG00011
OG00120
OG00223
OG00321
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
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.
Units
Counts
Participants
OG00011
OG00120
OG00223
OG00321
Title
Denominators
Categories
Title
Measurements
OG0000
OG0015.0
OG0024.3
OG0034.8
OG003
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.
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
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.
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Units
Counts
Participants
OG00027
OG00153
OG00255
OG00352
Title
Denominators
Categories
Title
Measurements
OG000-0.087± 0.2199
OG001-0.041± 0.2283
OG002-0.138± 0.5247
OG003-0.020± 0.2668
Units
Counts
Participants
OG00028
OG00153
OG00254
OG00353
Title
Denominators
Categories
Title
Measurements
OG000-0.338± 0.8922
OG001-0.079± 0.2912
OG002-0.197± 0.5757
OG003-0.088± 0.3700
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.
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Title
Measurements
OG0007.1
OG0013.8
OG00210.7
OG0031.8
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.
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Title
Measurements
OG00010.7
OG0013.8
OG00210.7
OG0033.6
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.
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Title
Measurements
OG00017.9
OG0015.7
OG00216.1
OG00314.5
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Title
Measurements
OG00053.6
OG00158.5
OG00259.3
OG00363.0
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Title
Measurements
OG00064.3
OG00162.3
OG00275.9
OG00375.5
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.
Units
Counts
Participants
OG00028
OG00153
OG00256
OG00355
Title
Denominators
Categories
Week 24
Title
Measurements
OG0000
OG0010
OG0021.8
OG0030
Week 48
Title
Measurements
OG0000
OG0013.8
OG0021.8
OG003
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.