Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02431312 | Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects | PHASE1 | COMPLETED | 90 | — | — | Jan 12, 2015 | May 22, 2018 | Oct 15, 2019 | 22 | United States, Australia +6 |
Composite outcome measure consisting of multiple measures, including: 1. Local pain immediately after Study Treatment/EP and at select times using a visual analog scale (VAS) from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" 2. Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP 3. Frequency and severity of laboratory abnormalities 4. Frequency and severity of all adverse events 5. Changes in vital signs
| Arm | Type | Description |
|---|---|---|
| Group A: low dose, standard regimen | EXPERIMENTAL | Participants received 3 or 4 doses of 0.3 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. |
| Group A: mid dose, standard regimen | EXPERIMENTAL | Participants received 3 or 4 doses of 2 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. |
| Group A: high dose, standard regimen | EXPERIMENTAL | Participants received 3 or 4 doses of 9 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. |
| Group B: mid dose, standard regimen | EXPERIMENTAL | Participants received 3 or 4 doses of 2 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. |
| Group B: high dose, standard regimen | EXPERIMENTAL | Participants received 3 or 4 doses of 9 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. |
| Active Control: nucleos(t)ide analogue treatment | ACTIVE_COMPARATOR | Participants continued treatment with nucleos(t)ide analogue treatment. |
| Name | Type | Description |
|---|---|---|
| INO-1800 | BIOLOGICAL | INO-1800 delivered by EP |
| INO-9112 | BIOLOGICAL | INO-9112 delivered by EP |
| Nucleos(t)ide Analogue Treatment | DRUG | Continued treatment with nucleos(t)ide analogue |
INCLUSION CRITERIA: * Chronic Hepatitis B virus infection * Negative for Hepatitis A IgM, C, D and HIV * Liver biopsy, Fibroscan® or equivalent elastography-based test obtained within the past 6 months demonstrating liver disease without evidence of bridging fibrosis or cirrhosis supported by plate...