Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PEGASYS [peginterferon alfa-2a]
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 for the treatment of chronic hepatitis B, including HBeAg negative chronic hepatitis B, and for high risk polycythemia vera. It is an investigational drug in clinical development for these conditions. The drug is being studied in patients aged 18 years and older.
PEGASYS is developed by Roche Holding AG, a company publicly traded under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's efficacy and safety in chronic hepatitis B and high risk polycythemia vera.
PEGASYS is in Phase 3 clinical development for chronic hepatitis B. It has completed a Phase 3 trial with 820 participants. Additionally, Phase 2 trials have been completed for HBeAg negative chronic hepatitis B and high risk polycythemia vera.
PEGASYS has completed clinical trials including NCT00048945, a Phase 3 study in chronic hepatitis B with 820 participants, and NCT00442572, a Phase 2 study in HBeAg negative chronic hepatitis B. Another completed trial is NCT01259817 for high risk polycythemia vera.
PEGASYS is also known as peginterferon alfa-2a (40KD). In clinical trials, it is referred to by this name, as seen in the study of intermittent long term treatment with PEGASYS in patients with HBeAg negative chronic hepatitis B.