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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003430-33 | EudraCT Number |
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A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro10 (dose level 1) | Experimental |
| |
| IgPro10 (dose level 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro10 | Biological | Normal human immunoglobulin G administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level | CIDP relapse, defined as a clinical decline relative to the previous assessment as indicated by an increase in modified Rankin Scale (mRS) of ≥ 1 point, in the Randomized Phase | Approximately 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level | Approximately 56 weeks | |
| Rate of TEAEs per infusion | Approximately 56 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Registration Coordinator | Contact | 6108784697 | +1 | clinicaltrials@cslbehring.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Completed | Phoenix | Arizona | 85016 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38353301 | Derived | Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4. |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rate of mild, moderate, and severe TEAEs per infusion by dose level |
| Approximately 56 weeks |
| Percentage of subjects with serious TEAEs | Approximately 56 weeks |
| Rate of serious TEAEs per infusion | Approximately 56 weeks |
| Percentage of subjects with related TEAEs | Approximately 56 weeks |
| Rate of related TEAEs per infusion | Approximately 56 weeks |
| Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase | Approximately 24 weeks |
| Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase | The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death) | Baseline and Approximately 24 weeks |
| Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level | CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit | Approximately 24 weeks |
| Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level | CIDP recovery in the Randomized Phase, defined as decrease in mRS score as comparedto baseline AND mRS score of 1 or 0 at end of Randomized Phase | Approximately 24 weeks |
| Time to CIDP relapse in Randomized Phase by dose level | Approximately 24 weeks |
| Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level | CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline | Approximately 24 weeks |
| Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level | CIDP recovery in the Dose Exploration Phase, defined as decrease in mRS score compared to baseline AND mRS score of 1 or 0 at end of DEP | Approximately 24 weeks |
| Time to CIDP Relapse in the Dose Exploration Phase by dose level | Approximately 24 weeks |
| Children's Hospital of Los Angeles |
| Withdrawn |
| Los Angeles |
| California |
| 90027 |
| United States |
| University of Iowa Hospitals and Clinics | Withdrawn | Iowa City | Iowa | 52242-1009 | United States |
| Akron Children's Hospital | Withdrawn | Akron | Ohio | 44647 | United States |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Le Bonheur Children's Hospital | Withdrawn | Memphis | Tennessee | 38105 | United States |
| Neurology Rare Disease Center | Recruiting | Flower Mound | Texas | 75028 | United States |
|
| Children's Specialty Group | Completed | Norfolk | Virginia | 23507 | United States |
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |