Phase 2
Completed N=178
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
Chronic HBV Infection
Source: ClinicalTrials.gov NCT01943799 ↗
Enrolled (actual)
178
Serious AEs
1.1%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline in HBsAg at Week 24 — -0.019; -0.020; -0.026; -0.048 log10 IU/mL — p=0.976
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HBsAg at Week 24 |
-0.019; -0.020; -0.026; -0.048 | 0.976 |
| SECONDARY Change From Baseline in HBsAg at Week 12 |
-0.004; -0.016; -0.017; -0.028 | — |
| SECONDARY Change From Baseline in HBsAg at Week 48 |
-0.043; -0.055; -0.051; -0.166 | — |
| SECONDARY Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 |
0; 0; 25.0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 |
0; 7.7; 33.3; 0; 0; 7.7 | — |
| SECONDARY Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 |
0; 0; 0; 0; 0; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01943799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.