Chronic inflammatory demyelinating polyradiculoneuropathy MedDRA version: 19.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Baxalta Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Has completed Epoch 1 of Study 161403 or Study 161601 without CIDP worsening. If female of childbearing potential, the subject must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (e.g. birth control pills/patches,intrauterine device (IUD), or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 134 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Subject has a serious medical condition such that in the opinion of the investigator the subject’s safety or medical care would be impacted by participation in this Extension Study. New medical condition that developed during participation in Study 161403 or Study 161601 that in the judgment of the investigator could increase risk to the subject or interfere with the evaluation of investigational medicinal product and/or conduct of the study. Subject is scheduled to participate in another, non-Baxalta clinical study involving an IP or investigational device during the course of this study. The subject is nursing or intends to begin nursing during the course of the study. Subject has participated in another clinical study involving an 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 or 161601) involving an IP or investigational device during the course of this study. The subject is a family member or employee of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety, tolerability, and immunogenicity of HYQVIA/HyQvia.;Secondary Objective: To assess the long-term effect of HYQVIA/HyQvia on clinical outcome measures, including prevention of relapse, change in functional ability, hand grip strength, and muscle strength. To assess the long-term effect of HYQVIA/HyQvia on quality of life, health utility, health resource utilization (HRU), treatment satisfaction, treatment preference, and subject global impression of change. To explore further the pharmacokinetics of HYQVIA/HyQvia in CIDP subjects.;Primary end point(s): Safety/Tolerability Number (percentage) of subjects experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs, respectively), regardless of causality Number (percentage) of subjects experiencing causally related SAEs and/or AEs Number (percentage) of subjects with serious and/or non-serious adverse reactions (ARs) plus suspected ARs Rate of AEs that may be a result of immune-mediated response to either immunoglobulin,rHuPH20, or other factors as listed in Table 12-1, expressed as number of events per infusion and per subject-year Number (percentage) of infusions associated with treatment-emergent SAEs and/or AEs, regardless of causality Number (percentage) of infusions associated with causally related SAEs and/or AEs Number (percentage) of infusions temporally associated with AEs (defined as AEs occurring during or within 72 hours after completion of an infusion) Number (percentage) of infusions associated with serious and/or non-serious ARs plus suspected ARs Number (percentage) of infusions associated with 1 or more systemic AEs Number (percentage) of infusions associated with 1 or more local infusion site reactions Number and proportion of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs Rates of systemic and local AEs, regardless of causality, ex | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Outcome measures Pharmacokinetics—Serum IgG levels Efficacy measures Proportion subjects who relapse EuroQoL HRU Treatment satisfaction Treatment preference Administration outcomes Number of sites per infusion Maximum volume per infusion site Time to administer the study product (immunoglobulin/rHuPH20) Monthly infusion time Number of subjects/caregivers unable to continue with self/home infusion and reason(s) for this failure. Maximum infusion rates Optional photo recording of infusion procedures ;Timepoint(s) of evaluation of this end point: Pharmacokinetics Timepoints: Week 1, 2, 13, 26, 39, 52, 65, 78, 91, 104 Efficacy measures Timepoints: Week 13, 26, 39, 52, 65, 78, 91, 104 EuroQoL Timepoints: Baseline, week 26, 52, 78 HRU Timepoints: Baseline, Week 13, 26, 39, 52, 65,78, 91, 104 Treatment satisfaction Timepoints: Baseline, week 26, 52, 78 Treatment preference Timepoints: Baseline, week 26, 52, 78 Administration outcomes Timepoints: Every 2, 3, or 4 weeks (every infusion) | — |
Countries
Canada, Colombia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Mexico, Norway, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom
Contacts
Public ContactAndras Nagy
Baxalta Innovation GmbH
Outcome results
None listed