NCT02955355

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

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

Timeline

• Start date: 2016-11-14
• Primary completion: 2023-07-04
• Completion: 2023-07-04
• First posted: 2016-11-04
• Last updated: 2024-08-28
• Results posted: 2024-08-28

Locations

35 sites across 18 countries: United States, Argentina, Brazil, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Poland, Serbia, Slovakia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study