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Also known as ISIS 14803
ISIS 14803, peginterferon alfa, ribavirin · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| ISIS 14803 | DRUG | - |
| ISIS 14803, peginterferon alfa, ribavirin | DRUG | - |
Inclusion Criteria Patients must meet the following inclusion criteria during screening: * Age greater than or equal to 18 years. * Both males and females are eligible. All patients should be advised that there are no data on the possible reproductive (teratological) effects of ISIS 14803. Theref...
ISIS 14803 was studied as a treatment for chronic hepatitis C virus infection. It was evaluated both as a single agent given intravenously and as an add-on to peginterferon alfa plus ribavirin in patients who had not responded adequately to those two drugs. It is an investigational therapy and is not approved for use.
ISIS 14803 was developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. The company sponsored the clinical program evaluating the drug in chronic hepatitis C, including a Phase 2 study of intravenous administration and a Phase 1 study of the drug added to peginterferon alfa and ribavirin.
ISIS 14803 reached Phase 2 clinical development for chronic hepatitis C. Two trials have been completed: a Phase 2 study of intravenous ISIS 14803 and a Phase 1 study adding ISIS 14803 to peginterferon alfa and ribavirin. No trials are currently active, and the drug is not approved.
ISIS 14803 has been studied in two completed trials. NCT00035945 was a Phase 2 study of intravenous ISIS 14803 in patients with chronic hepatitis C virus infection. NCT00062816 was a Phase 1 study adding ISIS 14803 to peginterferon and ribavirin in chronic hepatitis C patients who had not responded adequately to those two drugs.
The ISIS 14803 clinical program enrolled a total of 22 patients across its two completed trials. The Phase 1 study NCT00062816, which added ISIS 14803 to peginterferon alfa and ribavirin, enrolled 22 patients in the United States. Both studies enrolled adults aged 18 years and older.