ong-Term Tolerability and Safety of HYQVIA/HyQviain CIPD

Phase 1

• Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy; MedDRA version: 19.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000374-37-GR
• Lead Sponsor: Baxalta Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-28
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 149

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified