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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02166047
Ethics application status
Date submitted
16/06/2014
Date registered
18/06/2014
Date last updated
19/12/2016

Titles & IDs
Public title
Safety and Efficacy of GS-9620 for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Subjects
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 - GS-9620
Treatment: Drugs - Placebo to match GS-9620

Placebo Comparator: Placebo 4 Weeks (Cohort A) - Participants will receive placebo to match GS-9620 once a week for 4 weeks.

Experimental: GS-9620 1 mg 4 Weeks (Cohort A) - Participants will receive GS-9620 1 mg once a week for 4 weeks.

Experimental: GS-9620 2 mg 4 Weeks (Cohort A) - Participants will receive GS-9620 2 mg once a week for 4 weeks.

Experimental: GS-9620 4 mg 4 Weeks (Cohort A) - Participants will receive GS-9620 4 mg once a week for 4 weeks.

Placebo Comparator: Placebo 8 Weeks (Cohort B) - Participants will receive placebo to match GS-9620 once a week for 8 weeks.

Experimental: GS-9620 1 mg 8 Weeks (Cohort B) - Participants will receive GS-9620 1 mg once a week for 8 weeks.

Experimental: GS-9620 2 mg 8 Weeks (Cohort B) - Participants will receive GS-9620 2 mg once a week for 8 weeks.

Experimental: GS-9620 4 mg 8 Weeks (Cohort B) - Participants will receive GS-9620 4 mg once a week for 8 weeks.

Placebo Comparator: Placebo 12 Weeks (Cohort C) - Participants will receive placebo to match GS-9620 once a week for 12 weeks.

Experimental: GS-9620 1 mg 12 Weeks (Cohort C) - Participants will receive GS-9620 1 mg once a week for 12 weeks.

Experimental: GS-9620 2 mg 12 Weeks (Cohort C) - Participants will receive GS-9620 2 mg once a week for 12 weeks.

Experimental: GS-9620 4 mg 12 Weeks (Cohort C) - Participants will receive GS-9620 4 mg once a week for 12 weeks.


Treatment: Drugs: GS-9620
GS-9620 tablets administered orally every 7 days

Treatment: Drugs: Placebo to match GS-9620
Placebo to match GS-9620 tablets administered orally every 7 days

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

Outcomes
Primary outcome [1] 0 0
Mean change in log10 IU/ml serum hepatitis B surface antigen (HBsAg) from baseline to Week 24
Timepoint [1] 0 0
Up to Week 24
Secondary outcome [1] 0 0
Proportion of participants with hepatitis B e antigen (HBeAg) loss and seroconversion at Weeks 24 and 48
Timepoint [1] 0 0
Up to Week 48
Secondary outcome [2] 0 0
Proportion of participants with HBsAg loss and seroconversion at Weeks 24 and 48
Timepoint [2] 0 0
Up to Week 48
Secondary outcome [3] 0 0
Mean change in serum HBsAg from baseline to Weeks 4, 8, 12 and 48 (measured in log10 IU/mL)
Timepoint [3] 0 0
Up to Week 48
Secondary outcome [4] 0 0
Proportion of participants with virological breakthrough - Virological breakthrough is defined as having HBV DNA > 69 IU/ml with confirmation > 2 weeks after the initial test in the setting of satisfactory adherence to treatment with oral antivirals.
Timepoint [4] 0 0
Up to Week 12
Secondary outcome [5] 0 0
Proportion of participants with drug resistance mutations at Week 48
Timepoint [5] 0 0
Up to Week 48
Secondary outcome [6] 0 0
Proportion of participants with = 1 log10 decline in serum HBsAg titers from baseline at Weeks 4,8,12, 24 and 48
Timepoint [6] 0 0
Up to Week 48

Eligibility
Key inclusion criteria
- 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 chronic HBV infection (e.g. 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
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

- Lab parameters not within defined thresholds for neutropenia, anemia,
thrombocytopenia, leukopenia, or other evidence of inadequate liver function

- Co-infection 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 (e.g. 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 (e.g. chronic obstructive pulmonary disease)

- Retinal disease

- Immunodeficiency disorders

- Received solid organ or bone marrow transplant

- Received prolonged therapy with immunomodulators (e.g. corticosteroids) or biologics
(e.g. 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

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
The people assessing the outcomes
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
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
This study will evaluate the safety, tolerability, and efficacy of GS-9620 in virologically
suppressed adults with chronic hepatitis B virus (HBV) infection who are currently being
treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts.
Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of
the doses of GS-9620 (1, 2, or 4 mg) and all participants will continue on their current oral
antiviral treatment for the entire duration of the study. Cohorts A, B, and C will consist of
a different treatment period of 4, 8, or 12 weeks, respectively, and will be followed to Week
48. After Cohort A completes treatment, a safety review will be conducted by an external data
monitoring committee prior to beginning Cohort B. Another safety review will be conducted
after Cohort B completes treatment prior to beginning Cohort C.
Trial website
https://clinicaltrials.gov/show/NCT02166047
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