Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
Public ClinicalTrials.gov record NCT01545076. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP. Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.
Study identification
- NCT ID
- NCT01545076
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 208 participants
Conditions and interventions
Interventions
- IgPro20 (low dose) Biological
- Placebo Biological
- IgPro10 Biological
- IgPro20 (high dose) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2012
- Primary completion
- Aug 31, 2016
- Completion
- Aug 31, 2016
- Last update posted
- Jul 4, 2018
2012 – 2016
United States locations
- U.S. sites
- 22
- U.S. states
- 18
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site reference 8400181 | Birmingham | Alabama | 35233 | — |
| Site reference 8400173 | Phoenix | Arizona | 85013 | — |
| Site reference 8400172 | Phoenix | Arizona | 85018 | — |
| Site reference 8400167 | Los Angeles | California | 90033 | — |
| Site reference 8400077 | Centennial | Colorado | 80112 | — |
| Site Reference 8400352 | Washington D.C. | District of Columbia | 20037 | — |
| Site reference 8400214 | Miami | Florida | 33136 | — |
| Site reference 8400162 | Chicago | Illinois | 60611 | — |
| Site Reference 8400247 | Chicago | Illinois | 60611 | — |
| Site Reference 8400215 | Indianapolis | Indiana | 46202 | — |
| Site reference 8400166 | Kansas City | Kansas | 66160 | — |
| Site Reference 8400347 | New Brunswick | New Jersey | 08901 | — |
| Site reference 8400169 | New York | New York | 10021 | — |
| Site reference 8400179 | New York | New York | 10021 | — |
| Site reference 8400182 | Charlotte | North Carolina | 28204 | — |
| Site Reference 8400346 | Durham | North Carolina | 27710 | — |
| Site reference 8400178 | Columbus | Ohio | 43210 | — |
| Site reference 8400217 | Oklahoma City | Oklahoma | 73104 | — |
| Site Reference 8400177 | Nashville | Tennessee | 37232 | — |
| Site reference 8400164 | Houston | Texas | 77030 | — |
| Site Reference 8400268 | Charlottesville | Virginia | 22908 | — |
| Site Reference 8400340 | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01545076, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 4, 2018 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01545076 live on ClinicalTrials.gov.