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NCT02027701 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 3 study of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT02027701 is a Phase 3 study of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Polyradiculoneuropathy, Chronic Inflammatory Demyelinating that has completed, run by CSL Behring. The registered enrollment target is 82 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT02027701, a Phase 3 study of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).
Conditions Studied
Interventions
- BIOLOGICAL IgPro20
Study Locations (20)
Other
- Site Reference 2030009 - Hradec Králové
- Site Reference 2030002 - Hradec Králové
- Site Reference 2500022 - Nice
- Site Reference 2760069 - Berlin
- Site Reference 2760072 - Berlin
- Site Reference 2760049 - Bochum
- Site Reference 2760094 - Essen
- Site Reference 2760054 - Hanover
- Site Reference 2760055 - Leipzig
- Site Reference 2760047 - Potsdam
Alabama
- Site Reference 8400181 - Birmingham
California
- Site Reference 8400167 - Los Angeles
Kansas
- Site Reference 8400166 - Kansas City
New York
- Site Reference 8400169 - New York
North Carolina
- Site Reference 8400182 - Charlotte
Queensland
- Site Reference 0360017 - Woolloongabba
Victoria
- Site Reference 0360011 - Fitzroy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2014-07-30 |
| Est. Completion | 2017-07-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02027701
The ClinicalTrials.gov registry entry for NCT02027701 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) appearing as the primary indexed condition, and to 1 intervention - of which IgPro20 is the first listed.
NCT02027701 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT02027701 about?
NCT02027701 is a clinical study titled "Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)". 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 rescu...
What is the current status of trial NCT02027701?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 82 participants. The study started on 2014-07-30. Estimated completion is 2017-07-10.
What conditions does trial NCT02027701 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
What interventions are being tested in trial NCT02027701?
The interventions under investigation include: IgPro20 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02027701?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02027701 being conducted?
This trial has 20 study locations across Alabama, California, Kansas, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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