drugset / Trial / NCT02955355

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

NCT02955355

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-11-14
Primary completion
2023-07-04
Completion
2023-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Infusion 10% (Human) Unknown Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 80 iu Subcutaneous