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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02631096 | Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy | PHASE2 | COMPLETED | 36 | — | — | Dec 1, 2015 | May 18, 2018 | Jun 29, 2018 | 4 | Australia, New Zealand |
To evaluate the safety and tolerability of multiple doses of ARB-001467 in HBeAg-negative and HBeAg-positive subjects with chronic Hepatitis B virus infection who are receiving nucleos(t)ide analogue therapy
| Arm | Type | Description |
|---|---|---|
| 0.2 mg/kg ARB-001467 or Placebo | EXPERIMENTAL | HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.2 mg/kg versus placebo once a month for 3 months |
| 0.4 mg/kg ARB-001467 or Placebo | EXPERIMENTAL | HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months |
| ARB-001467 or Placebo | EXPERIMENTAL | HBeAg-positive subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months |
| 0.4 mg/kg ARB-001467 | EXPERIMENTAL | HBeAg-negative subjects receive ARB-001467 at. 0.4 mg/kg (open label) bi-weekly for 5 treatments and then subjects with HBsAg ≤1000 IU/mL AND ≥1.0 log10 decrease from baseline at Day 71 will continue monthly dosing through 48 weeks |
| Name | Type | Description |
|---|---|---|
| ARB-001467 | DRUG | An IV infusion of ARB-001467 |
| Placebo | OTHER | An IV infusion of placebo |
Key Inclusion Criteria: * Documented chronic HBV infection for ≥12 months prior to Screening Visit. * Quantitative HBsAg ≥1000 IU/mL at the Screening Visit. * Subjects currently receiving entecavir and/or tenofovir for ≥12 months and HBV DNA undetectable. Key Exclusion Criteria: * Known co-infect...