Phase 2
Completed N=162
Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants
Source: ClinicalTrials.gov NCT02166047 ↗Enrolled (actual)
162
Serious AEs
2.5%
Results posted
Sep 2020
Primary outcomePrimary: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24 — -0.011; 0.033; -0.018; -0.035 log10 IU/mL — p=0.590
Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).
Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24 |
-0.011; 0.033; -0.018; -0.035; -0.081; -0.081 | 0.590 |
| SECONDARY Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24 |
0.0; 0.0; 0.0; 0.0; 20.0; 0.0 | — |
| SECONDARY Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48 |
0.0; 0.0; 0.0; 0.0; 20.0; 0.0 | — |
| SECONDARY Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Serum HBsAg Level at Week 4 |
-0.009; 0.025; -0.008; -0.017; -0.003; 0.014 | — |
| SECONDARY Change From Baseline in Serum HBsAg Level at Week 8 |
-0.029; 0.002; -0.035; -0.013; 0.000; 0.006 | — |
| SECONDARY Change From Baseline in Serum HBsAg Level at Week 12 |
-0.050; 0.017; -0.004; -0.023; -0.031; -0.005 | — |
| SECONDARY Change From Baseline in Serum HBsAg Level at Week 48 |
-0.048; -0.055; -0.071; -0.067; -0.035; -0.024 | — |
Eligibility Criteria
Key Inclusion Criteria
- Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
- Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
- Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
- Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
- Must be willing and able to comply with all study requirements
Key Exclusion Criteria
- Extensive bridging fibrosis or cirrhosis
- Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
- Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
- Evidence of hepatocellular carcinoma
- 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.
- Significant cardiovascular, pulmonary, or neurological disease
- Any of the following conditions that may worsen in response to interferon (IFN):
- Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
- Poorly controlled diabetes mellitus
- Significant psychiatric disorders
- Thyroid disorder (unless controlled under treatment)
- Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
- Retinal disease
- Immunodeficiency disorders
- Received solid organ or bone marrow transplant
- Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
- Use of another investigational agents within 3 months of screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- Females who are pregnant or may wish to become pregnant during the study
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02166047). 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.