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RO5024048 · 7 trials · 2 indications
| 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. |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Normal Renal Function |
| 2 | EXPERIMENTAL | Mild Renal Impairment |
| 3 | EXPERIMENTAL | Moderate Renal Impairment |
| 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 |
| Placebo | DRUG | single oral dose |
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 was evaluated in combination with other antiviral agents, including danoprevir and ribavirin, in patients with genotype 1 chronic Hepatitis C, including those who were treatment-naïve or had previously not responded to interferon-based therapy.
RO5024048 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule and has not been approved by regulatory authorities.
RO5024048 has completed Phase 1 and Phase 2 clinical trials. All five trials listed for the drug are completed, with no active trials currently ongoing. The drug remains investigational and has not received regulatory approval.
RO5024048 has been studied in several completed clinical trials, including NCT00801255, NCT01278134, NCT01483742, and NCT01628094. These trials evaluated the drug in combination with other Hepatitis C treatments in patients with chronic genotype 1 infection, including those with compensated cirrhosis.
RO5024048 is an HCV polymerase inhibitor. It works by targeting the Hepatitis C virus polymerase enzyme, which is essential for viral replication. By inhibiting this enzyme, the drug aims to reduce viral load in patients with chronic Hepatitis C.
No, RO5024048 is not the same as danoprevir. RO5024048 is an HCV polymerase inhibitor, while danoprevir (also known as RO5190591) is an HCV protease inhibitor. In clinical trials, the two drugs were studied in combination with each other, along with other agents such as ritonavir and ribavirin.