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NCT02549170 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 3
Development phase
138
Enrollment target

NCT02549170 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 138 participants.

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The verdict

NCT02549170, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 3
Development phase
138 participants
Enrollment target

Study 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.

Interventions

  • BIOLOGICAL HYQVIA
  • BIOLOGICAL 0.25% albumin placebo solution with rHuPH20
  • BIOLOGICAL IGIV GAMMAGARD LIQUID/KIOVIG
  • BIOLOGICAL IGIV GAMUNEX®-C

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2015-12-15
Est. Completion 2022-02-23
Phase Phase 3

Sponsor

Baxalta now part of Shire

74 total trials

What the Registry Record Tells You About NCT02549170

The ClinicalTrials.gov registry entry for NCT02549170 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which HYQVIA is the first listed.

NCT02549170 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02549170 about?

NCT02549170 is a clinical study titled "A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)". 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 Par...

What is the current status of trial NCT02549170?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 138 participants. The study started on 2015-12-15. Estimated completion is 2022-02-23.

What interventions are being tested in trial NCT02549170?

The interventions under investigation include: HYQVIA (BIOLOGICAL), 0.25% albumin placebo solution with rHuPH20 (BIOLOGICAL), IGIV GAMMAGARD LIQUID/KIOVIG (BIOLOGICAL), IGIV GAMUNEX®-C (BIOLOGICAL).

Who is sponsoring clinical trial NCT02549170?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.