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Completed

NCT Number: NCT01943799

Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B

The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.

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Key information

Conditions

Chronic HBV Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Auckland Clinical Studies, Grafton, New Zealand

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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:

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Currently taking an approved HBV oral antiviral medication
  • Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months)
  • Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1 year)

Key Exclusion Criteria:

  • Cirrhosis
  • Inadequate liver function
  • Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)
  • Evidence of hepatocellular carcinoma
  • Significant cardiovascular, pulmonary, or neurological disease
  • Females who are pregnant or may wish to become pregnant during the study
  • Received solid organ or bone marrow transplant
  • Use of another investigational agents within 3 months of screening
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
  • History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease ulcerative colitis, autoimmune disease
  • Known hypersensitivity to study drug, metabolites or formulation excipients
  • 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

GS-4774

Biological

Administered as a subcutaneous injection every 4 weeks for a total of 6 doses

OAV Regimen

Drug

Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)

Primary outcomes

  1. Change From Baseline in HBsAg at Week 24

    Time frame: Baseline; Week 24

    The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.

Secondary outcomes

  1. Change From Baseline in HBsAg at Week 12

    Time frame: Baseline; Week 12

    The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.

  2. Change From Baseline in HBsAg at Week 48

    Time frame: Baseline; Week 48

    The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.

  3. Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24

    Time frame: Week 24

    HBsAg loss was defined as HBsAg level decreasing from >0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from < 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.

  4. Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48

    Time frame: Week 48

    HBsAg loss was defined as HBsAg level decreasing from >0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from < 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.

  5. Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24

    Time frame: Week 24

    HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.

  6. Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48

    Time frame: Week 48

    HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.

  7. Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48

    Time frame: Baseline; Weeks 12, 24, and 48

    HBsAg 1-log decline was defined as ≥ 1 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 17, 2013
Registry last updated
Nov 1, 2019

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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