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Completed

NCT Number: NCT02579382

Study to Evaluate 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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Adult males or females between the ages of 18-65
  • Chronic hepatitis B virus (HBV) infection
  • HBV deoxyribonucleic acid (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), human immunodeficiency virus (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.

Treatment and study plan

TDF

Drug

300 mg tablets administered orally once daily

Other names: Viread®

Vesatolimod

Drug

Tablets administered orally once a week (every 7 days) for 12 doses

Other names: GS-9620

Placebo

Drug

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

Primary outcomes

  1. Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24

    Time frame: Baseline; Week 24

    The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (> 19 vs ≤ 19 IU/L for females; > 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.

Secondary outcomes

  1. Percentage of Participants With 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. HBeAg seroconversion was defined as qualitative Hepatitis B Envelope Antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.

  2. Percentage of Participants With 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. HBeAg seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.

  3. 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. HBsAg seroconversion was defined as qualitative Hepatitis B Surface Antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.

  4. 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. HBsAg seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.

  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. Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12

    Time frame: Baseline to Week 12

    HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.

  8. Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24

    Time frame: Baseline to Week 24

    HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 24 post-baseline visit.

  9. Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48

    Time frame: Baseline to Week 48

    HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.

  10. Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24

    Time frame: Week 24

    LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.

  11. Percentage of Participants With HBV DNA < LLOQ at Week 48

    Time frame: Week 48

    LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.

  12. Percentage of Participants Experiencing Virologic Breakthrough

    Time frame: Weeks 24 and 48

    Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having had HBV DNA < 69 IU/mL or confirmed 1.0 log10 IU/mL or greater increase in HBV DNA from nadir. Confirmation requires 2 consecutive occurrences of elevation in HBV DNA to > 69 IU/mL after having had HBV DNA < 69 IU/mL or 1.0 log10 IU/mL or greater increases in HBV DNA from nadir.

  13. Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)

    Time frame: Baseline; Week 48

    Sequence analysis of the HBV pol/RT was attempted for any participant who had HBV DNA ≥ 69 IU/mL at Week 48 or early discontinuation. Results of the alignment of Week 48 and baseline sequence were reported as a change from baseline sequence.

  14. Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod

    Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose

    AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.

  15. PK Parameter: AUCinf of Vesatolimod

    Time frame: Week 11: 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: Week 11: 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: Week 11: 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: Week 11: 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: Week 11: 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: Week 11: 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: Week 11: 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: Week 11: 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Oct 19, 2015
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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