Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PegIntron · 3 trials · 5 indications
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
| Arm | Type | Description |
|---|---|---|
| PegIntron 1.5 ug/kg/wk plus REBETOL | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| PegIntron 1.0 ug/kg/wk plus REBETOL | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| PEGASYS 180 ug/wk Plus COPEGUS | ACTIVE_COMPARATOR | PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| Overall study population | EXPERIMENTAL | - |
| 0.25 Dose Group | EXPERIMENTAL | PegIntron 0.25 mcg/kg SC QW for 12 weeks |
| 0.5 Dose Group | EXPERIMENTAL | PegIntron 0.5 mcg/kg SC QW for 12 weeks |
| 1.0 Dose Group | EXPERIMENTAL | PegIntron 1.0 mcg/kg SC QW for 12 weeks |
| No-treatment Control | NO_INTERVENTION | No treatment (no placebo) |
| Name | Type | Description |
|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) | BIOLOGICAL | 1.5 ug/kg/week subcutaneously (SC) for 48 weeks |
| REBETOL (ribavirin; SCH 18908) | DRUG | weight based dose 800-1400 mg/day orally (PO) for 48 weeks |
| PEGASYS (peginterferon alfa-2a) | BIOLOGICAL | 180 ug/week SC administered for 48 weeks |
| COPEGUS (ribavirin) | DRUG | 1000-1200 mg/day PO for 48 weeks |
| PegIntron (peginterferon alfa-2b) | BIOLOGICAL | PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks |
INCLUSION CRITERIA: * Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid \[HCV RNA\] quantitative polymerase chain reaction \[qPCR\] plasma positive) * Individuals with HCV genotype 1 (mixed 1a/1b is acceptable) * Compensated liver disease * Pretreatment liver ...
PEG-Intron is used for HIV infections, hepatitis, melanoma, and hepatitis C, including chronic hepatitis C. It is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for these infectious disease and oncology indications.
PEG-Intron is a pegylated form of interferon alfa-2b, which targets the immune system to fight viral infections and certain cancers. It is being studied in HIV infections, hepatitis, melanoma, and chronic hepatitis C.
PEG-Intron is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials for this investigational drug in infectious disease and oncology indications.
PEG-Intron has completed Phase 3 clinical trials for HIV infections and chronic hepatitis C. It is an investigational drug that has not been approved by the FDA, and it remains in clinical development for these indications.
PEG-Intron has been studied in several clinical trials, including NCT00035360 for HIV infections, NCT00039871 for chronic hepatitis C, NCT00457418 for melanoma, and NCT03537274 for hepatitis C. All trials have been completed.
Yes, PEG-Intron is also known as SCH 54031. In clinical trials, it has been referred to as polyethylene glycol-interferon alfa-2b (PEG-Intron, SCH 54031).