ong-Term Tolerability and Safety of HYQVIA/HyQvia in CIPD

Phase 1

• Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy; MedDRA version: 21.1Level: 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-IT
• Lead Sponsor: BAXALTA INNOVATIONS GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

They completed Phase 1 of the 161403 study or study 161601 without showing any worsening in the CIDP.
In the case of fertile woman, the subject must have a negative pregnancy test at the baseline visit and agree to take appropriate birth control measures (for example, contraceptive pills / plasters, intrauterine devices [IUD] or diaphragms or condoms [for the partner ] with gel or spermicidal foam) for the entire duration 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

The subject has a serious medical condition such that, in the opinion of the investigator, participation in this extension study would have repercussions on the patient's safety or medical care.
A new medical condition that developed during participation in the 161403 study or in the 161601 study which, according to the investigator's judgment, could increase the risks to the subject or interfere with the evaluation of the experimental medicinal product and / or the
conducting the study.
The subject is expected to participate in another non-Baxalta clinical trial that provides an IP or an experimental device during the course of the present study.
The subject breastfeeds or intends to start breastfeeding during the course of the study.
The subject has already participated in another clinical trial that included the use of an IP or an experimental device within 30 days prior to enrollment or planned to participate in another clinical trial (with the exception of protocol 161403 or protocol 161601). ) which foresees the use of an IP or an experimental device during the course of the present study.
The subject is a family member or an employee of the experimenter.

Study & Design

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