Safety and Efficacy of GS-9620 for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Subjects
Status: | Active, not recruiting |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | June 2014 |
End Date: | October 2016 |
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
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.
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.
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
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
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