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Safety and Efficacy of GS-9620 for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02166047
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: GS-9620 Drug: Placebo to match GS-9620 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo 4 Weeks (Cohort A)
Participants will receive placebo to match GS-9620 once a week for 4 weeks.
Drug: Placebo to match GS-9620
Placebo to match GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 1 mg 4 Weeks (Cohort A)
Participants will receive GS-9620 1 mg once a week for 4 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 2 mg 4 Weeks (Cohort A)
Participants will receive GS-9620 2 mg once a week for 4 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 4 mg 4 Weeks (Cohort A)
Participants will receive GS-9620 4 mg once a week for 4 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Placebo Comparator: Placebo 8 Weeks (Cohort B)
Participants will receive placebo to match GS-9620 once a week for 8 weeks.
Drug: Placebo to match GS-9620
Placebo to match GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 1 mg 8 Weeks (Cohort B)
Participants will receive GS-9620 1 mg once a week for 8 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 2 mg 8 Weeks (Cohort B)
Participants will receive GS-9620 2 mg once a week for 8 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 4 mg 8 Weeks (Cohort B)
Participants will receive GS-9620 4 mg once a week for 8 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Placebo Comparator: Placebo 12 Weeks (Cohort C)
Participants will receive placebo to match GS-9620 once a week for 12 weeks.
Drug: Placebo to match GS-9620
Placebo to match GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 1 mg 12 Weeks (Cohort C)
Participants will receive GS-9620 1 mg once a week for 12 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 2 mg 12 Weeks (Cohort C)
Participants will receive GS-9620 2 mg once a week for 12 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

Experimental: GS-9620 4 mg 12 Weeks (Cohort C)
Participants will receive GS-9620 4 mg once a week for 12 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days




Primary Outcome Measures :
  1. Mean change in log10 IU/ml serum hepatitis B surface antigen (HBsAg) from baseline to Week 24 [ Time Frame: Up to Week 24 ]

Secondary Outcome Measures :
  1. Proportion of participants with hepatitis B e antigen (HBeAg) loss and seroconversion at Weeks 24 and 48 [ Time Frame: Up to Week 48 ]
  2. Proportion of participants with HBsAg loss and seroconversion at Weeks 24 and 48 [ Time Frame: Up to Week 48 ]
  3. Mean change in serum HBsAg from baseline to Weeks 4, 8, 12 and 48 (measured in log10 IU/mL) [ Time Frame: Up to Week 48 ]
  4. Proportion of participants with virological breakthrough [ Time Frame: Up to Week 12 ]
    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.

  5. Proportion of participants with drug resistance mutations at Week 48 [ Time Frame: Up to Week 48 ]
  6. Proportion of participants with ≥ 1 log10 decline in serum HBsAg titers from baseline at Weeks 4,8,12, 24 and 48 [ Time Frame: Up to Week 48 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166047


Locations
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United States, California
Los Angeles, California, United States, 90095
San Diego, California, United States, 92154
San Francisco, California, United States, 94118
San Jose, California, United States, 95128
United States, Hawaii
Honolulu, Hawaii, United States, 96734
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48202
United States, New York
Flushing, New York, United States, 11355
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Toronto, Ontario, Canada, M5G2C4
Toronto, Ontario, Canada, M5T 2S8
Italy
San Giovanni Rotondo, FG, Italy, 71013
Milan, Italy, 20122
Parma, Italy, 43126
Pisa, Italy, 56124
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Netherlands
Rotterdam, Netherlands, 3015 CE
New Zealand
Auckland, New Zealand, 1142
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02166047    
Other Study ID Numbers: GS-US-283-1059
2014-001400-22 ( EudraCT Number )
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: October 2016
Keywords provided by Gilead Sciences:
Hepatitis B
HBV
GS-9620
TLR-7 Agonist
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vesatolimod
Antiviral Agents
Anti-Infective Agents