Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Completed · Phase 3
Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
In brief
This study is an extension study to the pivotal study IgPro20\_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy. Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20\_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight \[bw\]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn. The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
Key facts
- Study ID
- NCT02027701
- Run by
- CSL Behring
- People needed
- 82
- Starts
- 2014-07-30
- Expected to finish
- 2017-07-10
- Last updated by the study team
- 2018-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
- Written informed consent for study participation obtained before undergoing any study-specific procedures.
You may not qualify if…
- Subject is unable to directly transition from study IgPro20_3003.
- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of investigational medicinal product, and/or conduct of the study.
Where it is running
- Site Reference 8400181 — Birmingham, Alabama, United States
- Site Reference 8400167 — Los Angeles, California, United States
- Site Reference 8400166 — Kansas City, Kansas, United States
- Site Reference 8400169 — New York, New York, United States
- Site Reference 8400182 — Charlotte, North Carolina, United States
- Site Reference 0360017 — Woolloongabba, Queensland, Australia
- Site Reference 0360011 — Fitzroy, Victoria, Australia
- Site Reference 1240009 — Toronto, Ontario, Canada
- Site Reference 1240007 — Greenfield Park, Quebec, Canada
- Site Reference 2030009 — Hradec Králové, Czechia
- Site Reference 2030002 — Hradec Králové, Czechia
- Site Reference 2500022 — Nice, France
- Site Reference 2760052 — Essen, North Rhine-Westphalia, Germany
- Site Reference 2760069 — Berlin, Germany
- Site Reference 2760072 — Berlin, Germany
- Site Reference 2760049 — Bochum, Germany
- Site Reference 2760094 — Essen, Germany
- Site Reference 2760054 — Hanover, Germany
- Site Reference 2760055 — Leipzig, Germany
- Site Reference 2760047 — Potsdam, Germany
- Site Reference 2760039 — Würzburg, Germany
- Site Reference 3800031 — Milan, Italy
- Site Reference 3920037 — Tokorozawa, Saitama, Japan
- Site Reference 3920035 — Ube, Yamaguchi, Japan
- Site Reference 3920038 — Chiba, Japan
Full record on ClinicalTrials.gov
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