Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Interleukin 28B testing · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Chronic hepatitis B patients | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Interleukin 28B testing | OTHER | Blood sampling for IL28B genotyping |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Chronic hepatitis B * Previous participation in study ML18253 * Administration of at least one dose of the study drug during ML18253 study Exclusion Criteria: * Patients not satisfying the above inclusion criteria will not be enrolled i...
Interleukin 28B testing is used to evaluate IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B who were treated with Pegasys (peginterferon alfa-2a) in study ML18253. It is an investigational test being studied in the context of chronic hepatitis B infection.
Interleukin 28B testing is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting research on this test in the context of chronic hepatitis B.
Interleukin 28B testing is in Phase 3 clinical development. It is an investigational test and has not been approved by regulatory authorities. One Phase 3 trial has been completed as part of its clinical evaluation.
Interleukin 28B testing has been evaluated in one completed clinical trial, NCT01697501. This Phase 3 study, conducted in Italy, enrolled 88 patients with HBeAg-negative chronic hepatitis B who were treated with Pegasys in study ML18253.
Interleukin 28B testing is not FDA approved. It is an investigational test still in clinical development, with one Phase 3 trial completed. The trial was uncontrolled and not randomized or double-blinded.