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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic HBV Infection

Treatments: Biological: GS-4774; Drug: OAV Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01943799

GS-US-330-0101

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 4 patient groups

OAV Alone

Experimental group

Description:

Participants will continue their prebaseline OAV regimen alone from baseline to Week 48.

Treatment:

Drug: OAV Regimen

OAV + GS-4774 2 YU

Experimental group

Description:

Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20.

Treatment:

Biological: GS-4774

Drug: OAV Regimen

OAV + GS-4774 10 YU

Experimental group

Description:

Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.

Treatment:

Biological: GS-4774

Drug: OAV Regimen

OAV + GS-4774 40 YU

Experimental group

Description:

Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.

Treatment:

Biological: GS-4774

Drug: OAV Regimen