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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: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT02549170 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 138 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of \>=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 poi
Interventions
- BIOLOGICAL HYQVIA
- BIOLOGICAL 0.25% albumin placebo solution with rHuPH20
- BIOLOGICAL IGIV GAMMAGARD LIQUID/KIOVIG
- BIOLOGICAL IGIV GAMUNEX®-C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2015-12-15 |
| Est. Completion | 2022-02-23 |
| Phase | Phase 3 |
What the finished NCT02549170 record still lists
NCT02549170 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which HYQVIA is the first listed.
NCT02549170 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02549170's enrollment target sits among peer trials
138 1577th of 2000 higher than 421 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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