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: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic HBV Infection
Biological: GS-4774
Drug: OAV Regimen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 175
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OAV Alone
Participants will continue their prebaseline OAV treatment alone from baseline to Week 48.
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 + 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.
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 + 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.
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 + 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.
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943799

Locations
United States, California
Dumont-UCLA Liver Transplant Center
Los Angeles, California, United States, 90095
Huntington Medical Research Institutes
Pasadena, California, United States, 91105
Kaiser Permanente
Sacramento, California, United States, 95825
Kaiser Permanente
San Diego, California, United States, 92154
Kaiser Permanente
San Francisco, California, United States, 94118
Silicon Valley Research Institute
San Jose, California, United States, 95128
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Maryland
Digestive Disease Associates, PA
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital and Health System
Detroit, Michigan, United States, 48202
United States, Missouri
St.Louis University
St. Louis, Missouri, United States, 63104
United States, New York
Medical Pro-care
Flushing, New York, United States, 11355
North Shore LIJ Health System
Manhasset, New York, United States, 11030
United States, Virginia
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia, United States, 23602
New Zealand
Auckland Clinical Studies
Grafton, New Zealand, 1141
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Anuj Gaggar, MD, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01943799     History of Changes
Other Study ID Numbers: GS-US-330-0101
Study First Received: September 12, 2013
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis B (HBV)
Oral antiviral (OAV)
GS-4774

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human

ClinicalTrials.gov processed this record on September 16, 2014