134
Participants
Start Date
April 1, 2022
Primary Completion Date
December 21, 2022
Study Completion Date
January 11, 2023
P1101 (Ropeginterferon alfa-2b)
"1. Name: P1101 (Ropeginterferon alfa-2b)~2. Dosage form: pre-filled syringe~3. Strength: A single dose of 250 mcg/0.5 mL~4. Dosage and administration: 250 mcg per subcutaneous injection~5. Mechanism of action (if known): Interferon work by binding to specific membrane receptors on the cell surface which in turn induce a complex sequence of intracellular events. These events include the induction of particular enzymes, suppression of cell proliferation, inhibition of virus replication in virus infected cells and immunomodulating activities.~6. Pharmacological category: Antineoplastic and immunomodulating agents/ Immunostimulants/ Cytokines"
SOC
SOC includes infection prevention and control measures, supportive care, dexamethasone, and antiviral agents. The SOC is based on the Taiwan Centers for Disease Control (CDC) guidance and investigator's discretion.
National Taiwan University Hospital, Taipei
National Taiwan University Hospital
OTHER