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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01943799
First received: September 12, 2013
Last updated: October 17, 2014
Last verified: October 2014

September 12, 2013
October 17, 2014
September 2013
September 2014   (final data collection date for primary outcome measure)
Mean change in log10 IU/mL serum hepatitis B surface antigen (HBsAg) from Baseline to Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01943799 on ClinicalTrials.gov Archive Site
  • Mean change in log10 IU/mL serum HBsAg from Baseline to Weeks 12 and 48 [ Time Frame: Baseline to Weeks 12 and 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with HBsAg loss and HBsAg seroconversion at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with hepatitis B e antigen (HBeAg) loss and HBeAg seroconversion at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with a 1-log decline in HBsAg at Weeks 12, 24, and 48 [ Time Frame: Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
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

This is a randomized, open-label, multicenter Phase 2 study to evaluate the safety and efficacy of GS-4774 in subjects with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral medication. One hundred and seventy-five subjects will be randomized in a 1:2:2:2 ratio to the treatment arms for 20 weeks.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic HBV Infection
  • Biological: GS-4774
    GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses
  • Drug: OAV Regimen
    Oral antiviral (OAV) regimen as administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
  • Experimental: OAV Alone
    Participants will continue their prebaseline OAV treatment alone from baseline to Week 48.
    Intervention: Drug: OAV Regimen
  • Experimental: OAV + GS-4774 2 YU
    Participants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20.
    Interventions:
    • Biological: GS-4774
    • Drug: OAV Regimen
  • Experimental: OAV + GS-4774 10 YU
    Participants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
    Interventions:
    • Biological: GS-4774
    • Drug: OAV Regimen
  • Experimental: OAV + GS-4774 40 YU
    Participants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
    Interventions:
    • Biological: GS-4774
    • Drug: OAV Regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
175
March 2015
September 2014   (final data collection date for primary outcome measure)

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 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] by for ≥ 1 year)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
New Zealand,   United States
 
NCT01943799
GS-US-330-0101
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Anuj Gaggar, MD, PhD Gilead Sciences
Gilead Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP