Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003.
- Conditions
- peripheral nerve damagepolyneuropathy1002146010012303
- Registration Number
- NL-OMON44389
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
1. Written informed consent for study IgPro20_3004 before any study-specific procedures are performed.
2. Subject has completed the pivotal study IgPro20_3003 (SC Week 25), or was successfully rescued from a CIDP relapse during the SC Treatment Period of study IgPro20_3003.
1. Subject is unable to directly transition from the pivotal study IgPro20_3003, ie, the subject is unable to have the baseline visit conducted at the same time as the completion visit for the pivotal study IgPro20_3003.
2. New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in pivotal study IgPro20_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of IMP, and/or conduct of the study. See Section 6.7 (Contraindications and Precautions for Further Dosing).
3. Pregnant or intention to become pregnant during the course of the study.
4. Female subjects of childbearing potential either not using, or not willing to continue to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>* Overall rate of AEs per infusion.</p><br>
- Secondary Outcome Measures
Name Time Method