Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO6864018 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo, Every Other Day (QOD) | PLACEBO_COMPARATOR | Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| Placebo, Once a Week (QWk) | PLACEBO_COMPARATOR | Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 1200 milligrams (mg) QOD | EXPERIMENTAL | RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 1200 mg QWk | EXPERIMENTAL | RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 800 mg QOD | EXPERIMENTAL | RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 800 mg QWk | EXPERIMENTAL | RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| Name | Type | Description |
|---|---|---|
| Entecavir | DRUG | Entecavir will be administered as per local labeling. |
| Placebo | DRUG | Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment. |
| RO6864018 | DRUG | Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment. |
| Tenofovir | DRUG | Tenofovir will be administered as per local labeling. |
Inclusion Criteria: * Chronic hepatitis B infection * Positive test for HBsAg for more than 6 months prior to randomization * HBsAg titer greater than or equal to (\>/=) 250 international units per milliliter (IU/mL) at Screening * Treatment with any nucleoside/nucleotide analogue for \>/= 1 year w...
RO6864018 is an investigational small molecule developed by Roche Holding AG for chronic hepatitis B virus infection. It was studied as a treatment for virologically suppressed patients with chronic HBV. It is a Phase 2 candidate and has not been approved for any indication.
RO6864018 was studied for the treatment of chronic hepatitis B virus infection in adults who were already virologically suppressed. The research focused on whether adding the drug could affect HBV infection in this patient population. It remains an investigational therapy and is not an approved treatment.
RO6864018 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the clinical research program for the compound in chronic hepatitis B.
RO6864018 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for chronic hepatitis B or any other indication.
RO6864018 was evaluated in one completed Phase 2 trial, NCT02391805, titled A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection. The randomized, double-blind, placebo-controlled study enrolled 31 participants across Hong Kong, Malaysia, New Zealand, Singapore, South Korea, and Taiwan.