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RO5024048 · 5 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| A: GT1a 3DAA | EXPERIMENTAL | including RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048 |
| B: GT1a 3DAA | EXPERIMENTAL | including RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048 |
| C: GT1a 2DAA | EXPERIMENTAL | including RO5466731, RO5190591, ritonavir and ribavirin \[Copegus\] |
| D: GT1b 3DAA | EXPERIMENTAL | including RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048 |
| E: GT1b 2DAA | EXPERIMENTAL | including RO54664731, RO5190591, ritonavir and ribavirin \[Copegus\] |
| Part II | EXPERIMENTAL | - |
| Combination without RO5024048 | EXPERIMENTAL | Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients |
| Combination with RO5024048 | EXPERIMENTAL | RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys \[peginterferon alfa-2a\] and ribavirin) in prior null responder patients |
| Arm B Extension | EXPERIMENTAL | All patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks. |
| RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B) | EXPERIMENTAL | - |
| RO5024048 and ritonavir-boosted danoprevir with Ribavirin (A) | EXPERIMENTAL | - |
| Arm A: With RO5024048 | EXPERIMENTAL | Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). |
| Arm B: Standard treatment | ACTIVE_COMPARATOR | Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. |
| Cohort A | EXPERIMENTAL | - |
| Cohort B | EXPERIMENTAL | - |
| Cohort C | EXPERIMENTAL | - |
| Cohort D | EXPERIMENTAL | - |
| Cohort E | EXPERIMENTAL | - |
| Cohort F | EXPERIMENTAL | - |
| Cohort G | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RO5024048 | DRUG | - |
| RO5190591 | DRUG | - |
| RO5466731 | DRUG | - |
| ribavirin [Copegus] | DRUG | - |
| ritonavir | DRUG | - |
| danoprevir | DRUG | 100 mg orally bid, 24 weeks |
| peginterferon alfa-2a [Pegasys] | DRUG | 180 mcg weekly, 24 weeks |
| ribavirin | DRUG | 1000-1200 mg/kg/day orally in two divided doses, 24 weeks |
| Copegus placebo | DRUG | 1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Chronic hepatitis C genotype 1 of \>/= 6 months duration at screening * Part 1 and Part 2: Naïve to treatment with interferon (pegylated or non-pegylated). Patients who have participated in studies investigating a direct-acting antiviral ...
RO5024048 is an investigational small molecule being studied for the treatment of chronic hepatitis C. It has been evaluated in Phase 2 clinical trials, both as part of combination regimens and with other direct-acting antivirals, in patients with chronic hepatitis C genotype 1 or 4.
RO5024048 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical trials evaluating this drug in chronic hepatitis C.
RO5024048 is in Phase 2 clinical development. It has not been approved by the FDA for any indication and remains an investigational agent. All five of its registered trials are Phase 2 studies, and all have been completed.
RO5024048 has been studied in five completed Phase 2 trials, including NCT01628094 (ANNAPURNA), NCT01483742, NCT01278134 (INFORM-SVR), and NCT01057667. These trials enrolled a total of 579 patients with chronic hepatitis C across multiple countries.