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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02579382




Registration number
NCT02579382
Ethics application status
Date submitted
15/10/2015
Date registered
19/10/2015
Date last updated
17/05/2019

Titles & IDs
Public title
A Study of 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
Scientific 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
Secondary ID [1] 0 0
2015-002017-30
Secondary ID [2] 0 0
GS-US-283-1062
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TDF
Treatment: Drugs - Vesatolimod
Treatment: Drugs - Placebo

Placebo Comparator: TDF + placebo - TDF + placebo

Experimental: TDF + vesatolimod 1 mg - TDF + vesatolimod 1 mg

Experimental: TDF + vesatolimod 2 mg - TDF + vesatolimod 2 mg

Experimental: TDF + vesatolimod 4 mg - TDF + vesatolimod 4 mg


Treatment: Drugs: TDF
300 mg tablets administered orally once daily

Treatment: Drugs: Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses

Treatment: Drugs: Placebo
Placebo administered orally once a week (every 7 days) for 12 doses

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change (Measured in log10 IU/mL) in Serum Hepatitis B Surface Antigen (HBsAg) from Baseline at Week 24
Timepoint [1] 0 0
Baseline; Week 24
Secondary outcome [1] 0 0
Proportions of Participants with Hepatitis B e Antigen (HBeAg) Loss and Seroconversion at Week 24
Timepoint [1] 0 0
Baseline; Week 24
Secondary outcome [2] 0 0
Proportions of Participants with Hepatitis B e Antigen (HBeAg) Loss and Seroconversion at Week 48
Timepoint [2] 0 0
Baseline; Week 48
Secondary outcome [3] 0 0
Proportions of Participants with HBsAg Loss and Seroconversion at Week 24
Timepoint [3] 0 0
Baseline; Week 24
Secondary outcome [4] 0 0
Proportions of Participants with HBsAg Loss and Seroconversion at Week 48
Timepoint [4] 0 0
Baseline; Week 48
Secondary outcome [5] 0 0
Mean Change (Measured in log10 IU/mL) in HBsAg from Baseline at Week 12
Timepoint [5] 0 0
Baseline; Week 12
Secondary outcome [6] 0 0
Mean Change (Measured in log10 IU/mL) in HBsAg from Baseline at Week 48
Timepoint [6] 0 0
Baseline; Week 48
Secondary outcome [7] 0 0
Proportions of Participants with a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 12
Timepoint [7] 0 0
Baseline; Week 12
Secondary outcome [8] 0 0
Proportions of Participants with a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 24
Timepoint [8] 0 0
Baseline; Week 24
Secondary outcome [9] 0 0
Proportions of Participants with a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 48
Timepoint [9] 0 0
Baseline; Week 48
Secondary outcome [10] 0 0
Proportions of Participants with Hepatitis B Virus (HBV) DNA < Lower Limit of Quantitation (LLOQ) at Week 24
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Proportions of Participants with Hepatitis B Virus (HBV) DNA < Lower Limit of Quantitation (LLOQ) at Week 48
Timepoint [11] 0 0
Week 48
Secondary outcome [12] 0 0
Proportion of Participants Experiencing Virologic Breakthrough
Timepoint [12] 0 0
Up to Week 12
Secondary outcome [13] 0 0
Proportion of Participants with Drug Resistance Mutations
Timepoint [13] 0 0
Up to Week 48
Secondary outcome [14] 0 0
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod - AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Timepoint [14] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [15] 0 0
PK Parameter: AUCinf of Vesatolimod - AUCinf is defined as the concentration of drug extrapolated to infinite time.
Timepoint [15] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [16] 0 0
PK Parameter: %AUCexp of Vesatolimod - %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
Timepoint [16] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [17] 0 0
PK Parameter: Cmax of Vesatolimod - Cmax is defined as the maximum concentration of drug.
Timepoint [17] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [18] 0 0
PK Parameter: Clast of Vesatolimod - Clast is defined as the last observable concentration of drug.
Timepoint [18] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [19] 0 0
PK Parameter: Tmax of Vesatolimod - Tmax is defined as the time (observed time point) of Cmax
Timepoint [19] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [20] 0 0
PK Parameter: Tlast of Vesatolimod - Tlast is defined as the time (observed time point) of Clast.
Timepoint [20] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [21] 0 0
PK Parameter: T1/2 of Vesatolimod - T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Timepoint [21] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [22] 0 0
PK Parameter: CL/F of Vesatolimod - CL/F is defined as the apparent oral clearance following administration of the drug.
Timepoint [22] 0 0
Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose

Eligibility
Key inclusion criteria
Key

- Adult males or females between the ages of 18-65

- Chronic HBV infection

- HBV DNA = 2000 IU/mL at screening

Key
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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), 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Hong Kong
State/province [8] 0 0
Kowloon
Country [9] 0 0
Italy
State/province [9] 0 0
Bologna
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Pisa
Country [12] 0 0
Italy
State/province [12] 0 0
San Giovanni Rotondo
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Daegu
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
Taiwan
State/province [16] 0 0
Dalin
Country [17] 0 0
Taiwan
State/province [17] 0 0
Kaohsiung
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02579382
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications