Overview

This trial is active, not recruiting.

Condition chronic hbv infection
Treatments gs-4774, oav regimen
Phase phase 2
Sponsor Gilead Sciences
Start date September 2013
End date September 2014
Trial size 175 participants
Trial identifier NCT01943799, GS-US-330-0101

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will continue their prebaseline OAV treatment alone from baseline to Week 48.
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)
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.
gs-4774
GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses
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)
Participants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
gs-4774
GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses
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)
Participants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
gs-4774
GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses
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)

Primary Outcomes

Measure
Mean change in log10 IU/mL serum hepatitis B surface antigen (HBsAg) from Baseline to Week 24
time frame: Baseline to Week 24

Secondary Outcomes

Measure
Mean change in log10 IU/mL serum HBsAg from Baseline to Weeks 12 and 48
time frame: Baseline to Weeks 12 and 48
Proportion of participants with HBsAg loss and HBsAg seroconversion at Weeks 24 and 48
time frame: Weeks 24 and 48
Proportion of participants with hepatitis B e antigen (HBeAg) loss and HBeAg seroconversion at Weeks 24 and 48
time frame: Weeks 24 and 48
Proportion of participants with a 1-log decline in HBsAg at Weeks 12, 24, and 48
time frame: Weeks 12, 24, and 48

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.