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Also known as PEGASYS [peginterferon alfa-2a], Pegylated Interferon Alfa-2a, Pegylated interferon (PEG-INF) alfa-2a, Peginterferon alfa-2a, Pegylated Interferon (PEG-IFN) alfa-2a, Peg-IFN alfa-2a, peginterferon alfa-2a [Pegasys], Pegylated Interferon Alfa (Peginterferon Alfa)
Pegasys · 3 trials · 4 indications
Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) \<20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).
| Arm | Type | Description |
|---|---|---|
| PEGASYS | EXPERIMENTAL | Patient will start at 45 micrograms per week and gradually increase to 180 micrograms per week. Pegasys will be supplied in prefilled syringes and are to be given subcutaneously. |
| Aspirin | ACTIVE_COMPARATOR | 81 or 100 mg daily. |
| No Intervention | NO_INTERVENTION | Participants were on non- specific anti-viral treatment. |
| Name | Type | Description |
|---|---|---|
| PEGASYS | DRUG | - |
| Aspirin | DRUG | 81 or 100 mg daily. |
| PEGASYS [peginterferon alfa-2a] | DRUG | There were 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment. |
Inclusion Criteria: * Clinical diagnosis of hepatitis B * Not pregnant Exclusion Criteria: * Treatment for hepatitis B in past 6 months * Other hepatitis infections * Severe liver disease * Pregnancy
Pegasys is used to treat chronic hepatitis B and high risk polycythemia vera. It is developed by Roche Holding AG and has been studied in both infectious disease and hematology settings, including a Phase 3 trial in chronic hepatitis B and a Phase 2 trial in high risk polycythemia vera and essential thrombocythemia.
Pegasys is made by Roche Holding AG, which trades under the ticker RHHBY. Roche is the developer behind the peginterferon alfa-2a program and sponsored the clinical trials evaluating Pegasys in chronic hepatitis B and in high risk polycythemia vera.
Pegasys has been evaluated in Phase 3 clinical development, including a completed Phase 3 trial in chronic hepatitis B. Additional completed studies include Phase 2 trials in high risk polycythemia vera and essential thrombocythemia and in HBeAg negative chronic hepatitis B. No active trials are currently listed for Pegasys.
Pegasys has been studied in completed trials including NCT00048945, a Phase 3 study of Pegasys in chronic hepatitis B with 820 patients across 17 countries, NCT01259817, a Phase 2 salvage therapy study in high risk polycythemia vera or essential thrombocythemia with 135 patients, and NCT00442572, a Phase 2 intermittent long term treatment study in HBeAg negative chronic hepatitis B.
Yes, Pegasys is the brand name for peginterferon alfa-2a. The two names refer to the same Roche Holding AG product, so searches for either term point to the same therapy and the same clinical trial program in chronic hepatitis B and high risk polycythemia vera.
Across the listed Pegasys trials, 841 patients were enrolled in total. The largest was the Phase 3 chronic hepatitis B study NCT00048945 with 820 patients, followed by the Phase 2 polycythemia vera and essential thrombocythemia study NCT01259817 with 135 patients and the Phase 2 chronic hepatitis B study NCT00442572 with 21 patients.