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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02166047




Registration number
NCT02166047
Ethics application status
Date submitted
16/06/2014
Date registered
18/06/2014
Date last updated
14/10/2020

Titles & IDs
Public title
Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants
Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
Secondary ID [1] 0 0
2014-001400-22
Secondary ID [2] 0 0
GS-US-283-1059
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 - Vesatolimod
Treatment: Drugs - Placebo

Placebo comparator: Placebo 4 Weeks (Cohort A) - Placebo tablet once a week for 4 weeks

Experimental: Vesatolimod 1 mg 4 Weeks (Cohort A) - Vesatolimod 1 mg tablet once a week for 4 weeks

Experimental: Vesatolimod 2 mg 4 Weeks (Cohort A) - Vesatolimod 2 mg tablet once a week for 4 weeks

Experimental: Vesatolimod 4 mg 4 Weeks (Cohort A) - Vesatolimod 4 mg tablet once a week for 4 weeks

Placebo comparator: Placebo 8 Weeks (Cohort B) - Placebo tablet once a week for 8 weeks

Experimental: Vesatolimod 1 mg 8 Weeks (Cohort B) - Vesatolimod 1 mg tablet once a week for 8 weeks

Experimental: Vesatolimod 2 mg 8 Weeks (Cohort B) - Vesatolimod 2 mg tablet once a week for 8 weeks

Experimental: Vesatolimod 4 mg 8 Weeks (Cohort B) - Vesatolimod 4 mg tablet once a week for 8 weeks

Placebo comparator: Placebo 12 Weeks (Cohort C) - Placebo tablet once a week for 12 weeks

Experimental: Vesatolimod 1 mg 12 Weeks (Cohort C) - Vesatolimod 1 mg tablet once a week for 12 weeks

Experimental: Vesatolimod 2 mg 12 Weeks (Cohort C) - Vesatolimod 2 mg tablet once a week for 12 weeks

Experimental: Vesatolimod 4 mg 12 Weeks (Cohort C) - Vesatolimod 4 mg tablet once a week for 12 weeks


Treatment: Drugs: Vesatolimod
Vesatolimod tablet administered orally

Treatment: Drugs: Placebo
Placebo to match vesatolimod tablet administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Change From Baseline in Serum HBsAg Level at Week 4
Timepoint [5] 0 0
Baseline; Week 4
Secondary outcome [6] 0 0
Change From Baseline in Serum HBsAg Level at Week 8
Timepoint [6] 0 0
Baseline; Week 8
Secondary outcome [7] 0 0
Change From Baseline in Serum HBsAg Level at Week 12
Timepoint [7] 0 0
Baseline; Week 12
Secondary outcome [8] 0 0
Change From Baseline in Serum HBsAg Level at Week 48
Timepoint [8] 0 0
Baseline; Week 48

Eligibility
Key inclusion criteria
Key

* Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
* Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
* Have been on approved HBV OAV treatment for = 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
* Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
* Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
* Must be willing and able to comply with all study requirements

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
* Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
* Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
* Evidence of hepatocellular carcinoma
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
* Significant cardiovascular, pulmonary, or neurological disease
* Any of the following conditions that may worsen in response to interferon (IFN):

* Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
* Poorly controlled diabetes mellitus
* Significant psychiatric disorders
* Thyroid disorder (unless controlled under treatment)
* Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
* Retinal disease
* Immunodeficiency disorders
* Received solid organ or bone marrow transplant
* Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
* Use of another investigational agents within 3 months of screening
* Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
* Females who are pregnant or may wish to become pregnant during 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 administering the treatment/s

Intervention assignment
Other
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
30/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/10/2016
Sample size
Target
Accrual to date
Final
162
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
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Manitoba
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Italy
State/province [9] 0 0
FG
Country [10] 0 0
Italy
State/province [10] 0 0
Milan
Country [11] 0 0
Italy
State/province [11] 0 0
Parma
Country [12] 0 0
Italy
State/province [12] 0 0
Pisa
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland

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 in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).

Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).
Trial website
https://clinicaltrials.gov/study/NCT02166047
Trial related presentations / publications
Boni C, Vecchi A, Rossi M, Laccabue D, Giuberti T, Alfieri A, Lampertico P, Grossi G, Facchetti F, Brunetto MR, Coco B, Cavallone D, Mangia A, Santoro R, Piazzolla V, Lau A, Gaggar A, Subramanian GM, Ferrari C. TLR7 Agonist Increases Responses of Hepatitis B Virus-Specific T Cells and Natural Killer Cells in Patients With Chronic Hepatitis B Treated With Nucleos(T)Ide Analogues. Gastroenterology. 2018 May;154(6):1764-1777.e7. doi: 10.1053/j.gastro.2018.01.030. Epub 2018 Jan 31.
Janssen HLA, Brunetto MR, Kim YJ, Ferrari C, Massetto B, Nguyen AH, Joshi A, Woo J, Lau AH, Gaggar A, Subramanian GM, Yoshida EM, Ahn SH, Tsai NCS, Fung S, Gane EJ. Safety, efficacy and pharmacodynamics of vesatolimod (GS-9620) in virally suppressed patients with chronic hepatitis B. J Hepatol. 2018 Mar;68(3):431-440. doi: 10.1016/j.jhep.2017.10.027. Epub 2017 Dec 11.
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/NCT02166047