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Also known as Nucleos(t)ide (NUC)
Nucleoside · 1 trial · 1 indication
HBsAg loss was defined as quantitative HBsAg \<0.05 international units/milliliters (IU/mL). The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants \*100. 95% confidence interval (CI) was calculated using the Clopper-Pearson method. Percentages have been rounded off.
| Arm | Type | Description |
|---|---|---|
| Nucleos(t)ide (NUC) Control Arm | ACTIVE_COMPARATOR | Participants will continue their background NUC therapy for the 48-week treatment period. At the end of the treatment period, in line with current CHB treatment guidelines, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| Core Protein Allosteric Modulator (CpAM; RO7049389) + Toll-like Receptor 7 (TLR7;RO7020531) + NUC | EXPERIMENTAL | Participants will receive RO7049389 (600 mg once daily \[QD\]) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg once every other day \[QOD\]) will be administered during Weeks 1-12 and Weeks 25-36. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| Short Interfering Ribonucleic acid (siRNA; RO7445482) (Dose1) + NUC | EXPERIMENTAL | Participants will receive RO7445482 (Dose 1) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| siRNA (RO7445482) (Dose 2) + NUC | EXPERIMENTAL | Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| siRNA (RO7445482) + Pegylated Interferon (PEG-IFN) + NUC | EXPERIMENTAL | Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. PEG-IFN will be administered at a dose of 180 μg once weekly (QW) for 48 weeks. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| siRNA (RO7445482) + CpAM (RO7049389) + NUC | EXPERIMENTAL | Participants will receive RO7445482 (Dose 2) and RO7049389 (600 mg QD) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| siRNA (RO7445482) + TLR7 (RO7020531) + NUC | EXPERIMENTAL | Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg QOD) will be administered during Weeks 13-24 and Weeks 37-48 (i.e., 2 treatment cycles of 12 weeks' duration each and 42 doses of RO7020531 for each cycle). At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| siRNA(RO7445482)+ Programmed Death Ligand-1 Locked Nucleic Acid (PD-L1 LNA; RO7191863) + NUC [1] | EXPERIMENTAL | Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 13-24, in addition to their background NUC therapy for the 24-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| siRNA (RO7445482) + PD-L1 LNA (RO7191863) + NUC [2] | EXPERIMENTAL | Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 25-36, in addition to their background NUC therapy for the 36-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met. |
| Name | Type | Description |
|---|---|---|
| Nucleos(t)ide (NUC) | DRUG | Nucleos(t)ide (NUC) will be administered orally |
| CpAM (RO7049389) | DRUG | CpAM (RO7049389) will be administered orally |
| TLR7 (RO7020531) | DRUG | TLR7 (RO7020531) will be administered orally |
| siRNA (RO7445482) | DRUG | siRNA (RO7445482) will be administered subcutaneously |
| PEG-IFN | DRUG | PEG-IFN will be administered subcutaneously |
| PD-L1 LNA (RO7191863) | DRUG | PD-L1 LNA (RO7191863) will be administered subcutaneously |
Inclusion Criteria: * Body mass index between 18 and 32 kg/m2 inclusive. * Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for \>=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for \>=12 months, having received the sam...
Nucleoside is an investigational small molecule being studied for the treatment of chronic hepatitis B, a long-term viral infection of the liver. It is being developed by Roche Holding AG and has been evaluated in a Phase 2 clinical trial in adults with this condition.
Nucleoside is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this small molecule in chronic hepatitis B.
Nucleoside is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this drug.
Nucleoside has been studied in one completed Phase 2 trial, NCT04225715, titled A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B. The trial enrolled 281 adults across multiple countries including Bulgaria, Canada, Chile, China, France, Hong Kong, New Zealand, Romania, South Korea, Spain, Taiwan, Thailand, and the United Kingdom.
Yes, Nucleoside is also known as Nucleos(t)ide (NUC). Both names refer to the same investigational small molecule being developed by Roche Holding AG for chronic hepatitis B.