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)

CompletadoFase 3ClinicalTrials.gov

ID: NCT02955355Tipo: INTERVENTIONALInicio: 14 de nov de 2016Fin estimado: 4 de jul de 2023

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

HYQVIA

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

Ubicaciones

Hosp.Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalBaxalta now part of Shire

ColaboradorTakeda Development Center Americas, Inc.

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