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Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants

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
Results First Posted : September 2, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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).


Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Vesatolimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
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
Actual Study Start Date : June 30, 2014
Actual Primary Completion Date : May 11, 2016
Actual Study Completion Date : October 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo 4 Weeks (Cohort A)
Placebo tablet once a week for 4 weeks
Drug: Placebo
Placebo to match vesatolimod tablet administered orally

Experimental: Vesatolimod 1 mg 4 Weeks (Cohort A)
Vesatolimod 1 mg tablet once a week for 4 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Experimental: Vesatolimod 2 mg 4 Weeks (Cohort A)
Vesatolimod 2 mg tablet once a week for 4 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Experimental: Vesatolimod 4 mg 4 Weeks (Cohort A)
Vesatolimod 4 mg tablet once a week for 4 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Placebo Comparator: Placebo 8 Weeks (Cohort B)
Placebo tablet once a week for 8 weeks
Drug: Placebo
Placebo to match vesatolimod tablet administered orally

Experimental: Vesatolimod 1 mg 8 Weeks (Cohort B)
Vesatolimod 1 mg tablet once a week for 8 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Experimental: Vesatolimod 2 mg 8 Weeks (Cohort B)
Vesatolimod 2 mg tablet once a week for 8 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Experimental: Vesatolimod 4 mg 8 Weeks (Cohort B)
Vesatolimod 4 mg tablet once a week for 8 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Placebo Comparator: Placebo 12 Weeks (Cohort C)
Placebo tablet once a week for 12 weeks
Drug: Placebo
Placebo to match vesatolimod tablet administered orally

Experimental: Vesatolimod 1 mg 12 Weeks (Cohort C)
Vesatolimod 1 mg tablet once a week for 12 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Experimental: Vesatolimod 2 mg 12 Weeks (Cohort C)
Vesatolimod 2 mg tablet once a week for 12 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620

Experimental: Vesatolimod 4 mg 12 Weeks (Cohort C)
Vesatolimod 4 mg tablet once a week for 12 weeks
Drug: Vesatolimod
Vesatolimod tablet administered orally
Other Name: GS-9620




Primary Outcome Measures :
  1. Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24 [ Time Frame: Baseline to Week 24 ]
    A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.


Secondary Outcome Measures :
  1. Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24 [ Time Frame: Week 24 ]

    HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.

    HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.

    Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.


  2. Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48 [ Time Frame: Week 48 ]

    HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.

    HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.

    Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.

    Only participants who were HBeAg+ at baseline were included.


  3. Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24 [ Time Frame: Week 24 ]

    HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.

    HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.

    Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.


  4. Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48 [ Time Frame: Week 48 ]

    HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.

    HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.

    Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.


  5. Change From Baseline in Serum HBsAg Level at Week 4 [ Time Frame: Baseline; Week 4 ]
  6. Change From Baseline in Serum HBsAg Level at Week 8 [ Time Frame: Baseline; Week 8 ]
  7. Change From Baseline in Serum HBsAg Level at Week 12 [ Time Frame: Baseline; Week 12 ]
  8. Change From Baseline in Serum HBsAg Level at Week 48 [ Time Frame: Baseline; 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

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 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 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.


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
Publications of Results:
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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 )
ACTRN12614000628640 ( Other Identifier: ANZCTR )
First Posted: June 18, 2014    Key Record Dates
Results First Posted: September 2, 2020
Last Update Posted: October 14, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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