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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02579382
Ethics application status
Date submitted
15/10/2015
Date registered
19/10/2015
Date last updated
18/05/2020

Titles & IDs
Public 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
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 - 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.


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 Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
Timepoint [1] 0 0
Baseline; Week 24
Secondary outcome [1] 0 0
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
Timepoint [4] 0 0
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
Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
Timepoint [7] 0 0
Baseline to Week 12
Secondary outcome [8] 0 0
Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
Timepoint [8] 0 0
Baseline to Week 24
Secondary outcome [9] 0 0
Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
Timepoint [9] 0 0
Baseline to Week 48
Secondary outcome [10] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Percentage of Participants With HBV DNA < LLOQ at Week 48
Timepoint [11] 0 0
Week 48
Secondary outcome [12] 0 0
Percentage of Participants Experiencing Virologic Breakthrough
Timepoint [12] 0 0
Weeks 24 and 48
Secondary outcome [13] 0 0
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
Timepoint [13] 0 0
Baseline; Week 48
Secondary outcome [14] 0 0
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
Timepoint [14] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [15] 0 0
PK Parameter: AUCinf of Vesatolimod
Timepoint [15] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [16] 0 0
PK Parameter: %AUCexp of Vesatolimod
Timepoint [16] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [17] 0 0
PK Parameter: Cmax of Vesatolimod
Timepoint [17] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [18] 0 0
PK Parameter: Clast of Vesatolimod
Timepoint [18] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [19] 0 0
PK Parameter: Tmax of Vesatolimod
Timepoint [19] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [20] 0 0
PK Parameter: Tlast of Vesatolimod
Timepoint [20] 0 0
Week 11: 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
Timepoint [21] 0 0
Week 11: 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
Timepoint [22] 0 0
Week 11: 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 hepatitis B virus (HBV) infection
* HBV deoxyribonucleic acid (DNA ) = 2000 IU/mL at screening

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
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), 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.

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
10/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2019
Sample size
Target
Accrual to date
Final
192
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/study/NCT02579382
Trial related presentations / publications
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02579382