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| Name | Class |
|---|---|
| ISA Pharmaceuticals B.V. | INDUSTRY |
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The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question[s] it aims to answer are:
Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs.
Researchers will compare the ISA104 vaccine to a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISA104 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISA104 | Drug | SLP vaccine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety according to AEs, SAEs | AEs, SAEs | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HBV specific Immunogenicity- following ISA104 vaccination | Number of IFN-y Elispots per well after 3 day stimulation with SLPs will correspond to immunogenicity. Elispots will be performed before (baseline) and after treatment | 6 months |
| Efficacy of ISA104 vaccination by using conventional biomarkers |
| Measure | Description | Time Frame |
|---|---|---|
| To study novel HBV disease markers in the study patient population to assist with treatment decisions and/or therapy response monitoring in general | Levels of HBcrAg | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Sprengers, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Drug |
Saline solution (0.9% NaCl) |
|
Levels of HBsAg, HBsAb, HBeAg, HBV DNA |
| 6 monts |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |