Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human),
Brief Summary: This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks) of IGIV therapy for at least 3 months prior to screening. In this double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6 months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for a period of 6 months.