Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Peginterferon alfa-2a · 1 trial · 1 indication
Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as "percentage of participants" with "MADRS scores \> 13" (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)
| Arm | Type | Description |
|---|---|---|
| Escitalopram | ACTIVE_COMPARATOR | After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram. |
| Placebo | PLACEBO_COMPARATOR | After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo. |
| Name | Type | Description |
|---|---|---|
| Escitalopram | DRUG | - |
| Placebo | DRUG | - |
| Peginterferon alfa-2a | DRUG | Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly. |
| Ribavirin | DRUG | Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks. |
Inclusion Criteria: * Chronic hepatitis C infection defined as positive anti-HCV antibodies and serum HCV-RNA \>1000 IU/ml, naive to antiviral treatment * age \>18 years Exclusion Criteria: * Antidepressive treatment within the last 3 years * Psychiatric diseases including major depressive disord...
Peginterferon alfa-2a is being studied for the prevention of depression associated with PEGASYS treatment in hepatitis C virus-infected patients. It is in Phase 3 clinical development for this use. The drug is being investigated in a randomized, double-blind, placebo-controlled trial.
Peginterferon alfa-2a is being developed by Pulmonx Corporation, a company traded on the NASDAQ under the ticker symbol LUNG. The company is conducting clinical research on this drug for the prevention of depression in hepatitis C patients.
Peginterferon alfa-2a is in Phase 3 clinical development. It is being studied for the prevention of PEGASYS-associated depression in hepatitis C virus-infected patients. The drug is investigational and has not been approved by regulatory authorities.
Peginterferon alfa-2a is being studied in a completed Phase 3 clinical trial with the identifier NCT00136318. This trial enrolled 208 participants in Germany and evaluated the drug for the prevention of depression in hepatitis C virus-infected patients. The trial was randomized, double-blind, and placebo-controlled.
Peginterferon alfa-2a is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the prevention of depression in hepatitis C virus-infected patients. The drug has not completed the regulatory approval process.