157
Participants
Start Date
May 13, 2020
Primary Completion Date
August 19, 2022
Study Completion Date
December 8, 2022
Peginterferon Lambda-1A
Peginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain. Peginterferon lambda Injection is a sterile, nonpyrogenic, ready-to-use solution (0.4 mg/mL) that is clear to opalescent, colorless to pale yellow, and essentially free of particles. Lambda Injection is provided in a 1-mL long Type I glass syringe (0.18 mg/syringe) with a staked 29-gauge, 1/2- inch, thin-walled needle. The syringe has a rigid needle shield and is stoppered with a plunger stopper. Syringes are prefilled with a solution of Peginterferon lambda Injection, mannitol, L-histidine, polysorbate 80, hydrochloric acid, and water for injection; they are intended for a single use at adjustable doses. The syringe is marked with dose indicator lines, which are used as a reference point for administering the correct dose.
placebo
injection of 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse.
Hospital das Clínicas da Faculdade de Medicina de Botucatu, Botucatu
Hospital Alemão Oswaldo Cruz, São Paulo
Hospital das Clínicas São Paulo, São Paulo
University of Calgary, Calgary
Michael Garron Hospital, Toronto
Sunnybrook Health Sciences Centre, Toronto
University Health Network, Toronto
Michael Garron Hospital
OTHER
University Health Network, Toronto
OTHER