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

NCT02549170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-05-24

Study results available
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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

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

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2022-02-23
Completion
2022-02-23
FDA Drug
Yes

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549170 on ClinicalTrials.gov