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A Study of the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

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ClinicalTrials.gov Identifier: NCT02579382
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : May 17, 2019
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 (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
Actual Study Start Date : November 10, 2015
Actual Primary Completion Date : January 16, 2017
Actual Study Completion Date : May 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: TDF + placebo
TDF + placebo
Drug: TDF
300 mg tablets administered orally once daily
Other Name: Viread®

Drug: Placebo
Placebo administered orally once a week (every 7 days) for 12 doses

Experimental: TDF + vesatolimod 1 mg
TDF + vesatolimod 1 mg
Drug: TDF
300 mg tablets administered orally once daily
Other Name: Viread®

Drug: Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
Other Name: GS-9620

Experimental: TDF + vesatolimod 2 mg
TDF + vesatolimod 2 mg
Drug: TDF
300 mg tablets administered orally once daily
Other Name: Viread®

Drug: Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
Other Name: GS-9620

Experimental: TDF + vesatolimod 4 mg
TDF + vesatolimod 4 mg
Drug: TDF
300 mg tablets administered orally once daily
Other Name: Viread®

Drug: Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
Other Name: GS-9620




Primary Outcome Measures :
  1. Mean Change (Measured in log10 IU/mL) in Serum Hepatitis B Surface Antigen (HBsAg) from Baseline at Week 24 [ Time Frame: Baseline; Week 24 ]

Secondary Outcome Measures :
  1. Proportions of Participants with Hepatitis B e Antigen (HBeAg) Loss and Seroconversion at Week 24 [ Time Frame: Baseline; Week 24 ]
  2. Proportions of Participants with Hepatitis B e Antigen (HBeAg) Loss and Seroconversion at Week 48 [ Time Frame: Baseline; Week 48 ]
  3. Proportions of Participants with HBsAg Loss and Seroconversion at Week 24 [ Time Frame: Baseline; Week 24 ]
  4. Proportions of Participants with HBsAg Loss and Seroconversion at Week 48 [ Time Frame: Baseline; Week 48 ]
  5. Mean Change (Measured in log10 IU/mL) in HBsAg from Baseline at Week 12 [ Time Frame: Baseline; Week 12 ]
  6. Mean Change (Measured in log10 IU/mL) in HBsAg from Baseline at Week 48 [ Time Frame: Baseline; Week 48 ]
  7. Proportions of Participants with a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 12 [ Time Frame: Baseline; Week 12 ]
  8. Proportions of Participants with a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 24 [ Time Frame: Baseline; Week 24 ]
  9. Proportions of Participants with a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 48 [ Time Frame: Baseline; Week 48 ]
  10. Proportions of Participants with Hepatitis B Virus (HBV) DNA < Lower Limit of Quantitation (LLOQ) at Week 24 [ Time Frame: Week 24 ]
  11. Proportions of Participants with Hepatitis B Virus (HBV) DNA < Lower Limit of Quantitation (LLOQ) at Week 48 [ Time Frame: Week 48 ]
  12. Proportion of Participants Experiencing Virologic Breakthrough [ Time Frame: Up to Week 12 ]
  13. Proportion of Participants with Drug Resistance Mutations [ Time Frame: Up to Week 48 ]
  14. Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  15. PK Parameter: AUCinf of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    AUCinf is defined as the concentration of drug extrapolated to infinite time.

  16. PK Parameter: %AUCexp of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.

  17. PK Parameter: Cmax of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    Cmax is defined as the maximum concentration of drug.

  18. PK Parameter: Clast of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    Clast is defined as the last observable concentration of drug.

  19. PK Parameter: Tmax of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    Tmax is defined as the time (observed time point) of Cmax

  20. PK Parameter: Tlast of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    Tlast is defined as the time (observed time point) of Clast.

  21. PK Parameter: T1/2 of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  22. PK Parameter: CL/F of Vesatolimod [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    CL/F is defined as the apparent oral clearance following administration of the drug.



Information from the National Library of Medicine

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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:

  • Adult males or females between the ages of 18-65
  • Chronic HBV infection
  • HBV DNA ≥ 2000 IU/mL at screening

Key Exclusion Criteria:

  • Extensive bridging fibrosis or cirrhosis
  • Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
  • Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
  • Chronic liver disease other than HBV
  • Lactating or pregnant females or those that wish to become pregnant during the course of 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): NCT02579382


Locations
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United States, California
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Maryland
Catonsville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
Flushing, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Canada, Ontario
Toronto, Ontario, Canada
Hong Kong
Kowloon, Hong Kong
Italy
Bologna, Italy
Milano, Italy
Pisa, Italy
San Giovanni Rotondo, Italy
Korea, Republic of
Daegu, Korea, Republic of
Seoul, Korea, Republic of
New Zealand
Grafton, Auckland, New Zealand
Taiwan
Dalin, Taiwan
Kaohsiung, Taiwan
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02579382     History of Changes
Other Study ID Numbers: GS-US-283-1062
2015-002017-30 ( EudraCT Number )
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
HBV
Hepatitis
Liver Disease
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Tenofovir
Hepatitis A
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents