Phase 2
Completed N=67
Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment
Source: ClinicalTrials.gov NCT03615066 ↗Enrolled (actual)
67
Serious AEs
1.5%
Results posted
Jan 2021
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 percentage of participants
Summary
The primary objectives of this study are to evaluate the safety and tolerability of multiple oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult participants with chronic hepatitis B (CHB) who are viremic and not currently being treated.
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 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
84.6; 60.7; 76.9 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Laboratory Abnormalities |
84.6; 92.9; 92.3 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 |
0; 0; 0 | — |
| SECONDARY Change From Baseline in Serum qHBsAg at Week 4 |
-0.04; -0.01; -0.02 | — |
| SECONDARY Change From Baseline in Serum qHBsAg at Week 8 |
-0.04; -0.05; 0.00 | — |
| SECONDARY Change From Baseline in Serum qHBsAg at Week 12 |
-0.04; -0.05; 0.01 | — |
| SECONDARY Change From Baseline in Serum qHBsAg at Week 24 |
-0.08; -0.11; -0.03 | — |
| SECONDARY Change From Baseline in Serum qHBsAg at Week 48 |
-0.12; -0.16; -0.12 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < Lower Limit of Quantification (LLOQ) at Week 12 |
20.8; 28.6; 25.0 | — |
| SECONDARY Percentage of Participants With HBV DNA < LLOQ at Week 24 |
37.5; 32.1; 33.3 | — |
| SECONDARY Percentage of Participants With HBV DNA < LLOQ at Week 48 |
50.0; 44.4; 45.5 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss at Week 24 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss at Week 48 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With Virologic Breakthrough From Baseline up to Week 24 |
3.8; 7.1; 15.4 | — |
| SECONDARY Percentage of Participants With Virologic Breakthrough From Baseline up to Week 48 |
3.8; 10.7; 15.4 | — |
| SECONDARY Percentage of Participants With Drug Resistance Mutations |
0; 0; 0 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod |
1163.0; 548.0; 1441.8; 491.2 | — |
| SECONDARY PK Parameter: AUC0-24 of Selgantolimod |
1162.2; 547.7; 1440.5; 494.4 | — |
| SECONDARY PK Parameter: AUCinf of Selgantolimod |
1184.2; 556.4; 1462.8; 503.2 | — |
| SECONDARY PK Parameter: Cmax of Selgantolimod |
373.3; 307.7; 591.0; 268.2 | — |
| SECONDARY PK Parameter: Tmax of Selgantolimod |
0.98; 0.53; 0.55; 0.50 | — |
| SECONDARY PK Parameter: CL/F of Selgantolimod |
4094330.4; 4603039.8; 4550308.6; 6223868.1 | — |
| SECONDARY PK Parameter: t1/2 of Selgantolimod |
4.55; 5.13; 4.78; 5.03 | — |
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 male and non-pregnant, non-lactating females
- Documented evidence of chronic hepatitis B virus (HBV) infection with detectable hepatitis B surface antigen (HBsAg) levels at screening
- Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 international units per milliliter (IU/mL).
- Screening electrocardiogram (ECG) without clinically significant abnormalities
Key Exclusion Criteria
- Extensive bridging fibrosis or cirrhosis
- Received a commercially available HBV OAV treatment(s) within the 3 months prior to screening.
- Received prolonged therapy with immunomodulators or biologics within 3 months of screening
- Individuals meeting any of the following laboratory parameters at screening:
- Alanine aminotransferase > 5 * upper limit of normal (ULN)
- International normalized ratio > ULN unless the individual is stable on an anticoagulant regimen
- Albumin 1.5x ULN
- Platelet Count < 100,000/µL
- Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus or hepatitis D virus
- Prior history of hepatocellular carcinoma 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.
- 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 (NCT03615066). 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.