NCT02549170

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to learn more about the following treatment options in adults with CIDP: * Subcutaneous self-infusion with HyQvia. * Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound. The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C. The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.

Conditions

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

Type	Name	Description
BIOLOGICAL	HYQVIA	Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
BIOLOGICAL	0.25% albumin placebo solution with rHuPH20	Participants will receive placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20.
BIOLOGICAL	IGIV GAMMAGARD LIQUID/KIOVIG	Participants will receive GAMMAGARD LIQUID/KIOVIG
BIOLOGICAL	IGIV GAMUNEX®-C	Participants will receive GAMUNEX®-C

Timeline

• Start date: 2015-12-15
• Primary completion: 2022-02-23
• Completion: 2022-02-23
• First posted: 2015-09-15
• Last updated: 2023-05-24
• Results posted: 2023-05-24

Locations

83 sites across 22 countries: United States, Argentina, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Mexico, Norway, Poland, Serbia, Slovakia, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study