CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 85 enrolled
Drug / intervention
HYQVIAbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02955355
NCT02955355Phase 3Completed
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Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Baxalta now part of Shire·interventional·Posted Nov 4, 2016·Updated Aug 28, 2024

In Brief

A Phase 3 clinical trial evaluating HYQVIA for Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Completed, enrolled 85 participants across 35 sites in 18 countries.

Detailed Summary

Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study. The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia. All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so. Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Inflammatory Demyelinating Polyradiculoneuropathy
CountriesArgentina, Brazil, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Poland, Serbia, Slovakia, Spain, Turkey (Türkiye), United Kingdom, United States
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 4, 2016
Enrollment StartNov 14, 2016
Primary CompletionJul 4, 2023
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 9.7 years ago

Interventions

HYQVIAbiological

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