Clinical Trial

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), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Dimensions: NCT02549170

Affiliations

Organisations

  1. (1) Barrow Neurological Institute, grid.427785.b
  2. (2) University of Colorado Anschutz Medical Campus, grid.430503.1
  3. (3) University of Kansas Medical Center, grid.412016.0
  4. (4) Rutgers, The State University of New Jersey, grid.430387.b
  5. (5) Cleveland Clinic, grid.239578.2
  6. (6) The University of Texas Health Science Center at Houston, grid.267308.8
  7. (7) Instituto de Neurologia de Curitiba, grid.419114.8
  8. (8) London Health Sciences Centre, grid.412745.1
  9. (9) Klinički Bolnički Centar Rijeka, grid.412210.4
  10. (10) Centre Hospitalier Universitaire de Nice, grid.410528.a
  11. (11) Hôpital de la Timone, grid.411266.6
  12. (12) University of Göttingen, grid.7450.6
  13. (13) University Hospital Leipzig, grid.411339.d
  14. (14) General University Hospital of Patras, grid.412458.e
  15. (15) Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, grid.416850.e
  16. (16) Klinički centar Niš, grid.418653.d
  17. (17) Bellvitge University Hospital, grid.411129.e
  18. (18) Vall d'Hebron Hospital Universitari, grid.411083.f

Sponsors/collaborators

Abstract

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.

Methods

Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention: Participants will receive subcutaneous (SC) HYQVIA/HyQvia which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).

Recruitment information

Gender: All

Trial period

2016-2021

Phase

Phase 3

Research Categories

Main Subject Area

Fields of Research

External sources

Access at Registry