Phase 2
Completed N=48
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
Source: ClinicalTrials.gov NCT03491553 ↗Enrolled (actual)
48
Serious AEs
8.3%
Results posted
Apr 2020
Primary outcomePrimary: Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 — 0; 0; 0; 10.0 percentage of participants
Summary
The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 |
0; 0; 0; 10.0; 0; 0 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 |
0; 0; 0; 10.0; 0; 0 | — |
| SECONDARY Change From Baseline in Serum qHBsAg at Week 4 |
0.02; -0.07; 0.00; -0.01; -0.02; -0.03 | — |
| SECONDARY Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 |
0.00; -0.05; -0.01; -0.04; 0.02; -0.03 | — |
| SECONDARY Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 |
-0.01; -0.05; 0.00; -0.04; 0.05; 0.00 | — |
| SECONDARY Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 |
0.01; -0.05; -0.05; -0.16; -0.02; -0.01 | — |
| SECONDARY Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 |
-0.01; -0.05; -0.07; -0.17; 0.00; -0.05 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 |
0; 10.0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss at Week 24 |
0; 10.0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss at Week 48 |
0; 10.0; 0; 10.0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 |
0; 10.0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 |
0; 10.0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 |
22.2; 10.0; 0; 11.1; 0; 0 | — |
| SECONDARY Percentage of Participants With Virologic Breakthrough |
— | — |
| SECONDARY Percentage of Participants With Drug Resistance Mutations |
— | — |
Eligibility Criteria
Key Inclusion Criteria
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Adult males and non-pregnant, non-lactating females
- Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels
- On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
- HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening
- Screening Electrocardiogram (ECG) without clinically significant abnormalities
Key Exclusion Criteria
- Extensive bridging fibrosis or cirrhosis
- Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:
- Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)
- International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen
- Albumin 1.5x ULN
- Platelet Count < 100,000/uL
- Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)
- Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus
- Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging
- Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.
- Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease
- Received solid organ or bone marrow transplant
- Received prolonged therapy with immunomodulators or biologics within 3 months of screening
- Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03491553). 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.