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

Completed · Phase 3

Conditions studied: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

In brief

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.

Key facts

Study ID

NCT02955355

Run by

Baxalta now part of Shire

People needed

85

Starts

2016-11-14

Expected to finish

2023-07-04

Last updated by the study team

2024-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has completed Epoch 1 of Study 161403 without CIDP worsening.
• If female of childbearing potential, the participant must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study.

You may not qualify if…

• Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study.
• New medical condition that developed during participation in study 161403 that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of investigational medicinal product (IMP) and/or conduct of the study.
• Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this study.
• The participant is nursing or intends to begin nursing during the course of the study
• Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study (with the exception of study 161403) involving an IP or investigational device during the course of this study.
• The participant is a family member or employee of the investigator.

Where it is running

• Arizona Neuromuscular Research Center — Phoenix, Arizona, United States
• Hosp.Britanico de Buenos Aires — Ciudad Autonoma Buenos Aires, Argentina
• Instituto de Neurologia de Curitiba - Hospital Ecoville — Curitiba, Paraná, Brazil
• University of Alberta Hospital — Edmonton, Alberta, Canada
• LHSC - University Hospital — London, Ontario, Canada
• Toronto General Hospital, University Health Network — Toronto, Ontario, Canada
• Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA" — Medellín, Colombia
• Fakultni nemocnice Ostrava — Ostrava, Poruba, Czechia
• Fakultni nemocnice v Motole — Prague, Czechia
• Århus Universitetshospital — Aarhus C, Denmark
• CHU de Nice — Nice, Alpes Maritimes, France
• Groupe Hospitalier Pellegrin - Hôpital Pellegrin — Bordeaux, Gironde, France
• Hopital Neurologique Pierre Wertheimer — Bron, Rhone, France
• Universitaetsklinikum Leipzig AoeR — Leipzig, Saxony, Germany
• University Hospital of Patra — Pátrai, Greece
• Azienda Ospedaliero Universitaria San Martino — Genova, Italy
• Azienda Ospedaliera Universitaria Policlinico G. Martino — Messina, Italy
• Fondazione Istituto Neurologico Casimiro Mondino — Pavia, Italy
• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
• Azienda Ospedaliero-Universitaria Santa Maria della Misericordia — Udine, Italy
• Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran — Mexico City, Mexico City, Mexico
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego — Lodz, Poland
• Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie — Lublin, Poland
• Clinical Center of Serbia — Belgrade, Serbia

Full record on ClinicalTrials.gov

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