Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03684018 |
Recruitment Status :
Recruiting
First Posted : September 25, 2018
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Biological: IgPro10 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP |
Actual Study Start Date : | February 28, 2019 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | January 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: IgPro10 (single dose) |
Biological: IgPro10
Normal human immunoglobulin G administered intravenously
Other Name: Privigen |
Experimental: IgPro10 (multiple dose) |
Biological: IgPro10
Normal human immunoglobulin G administered intravenously
Other Name: Privigen |
- Percentage (%) of subjects with CIDP relapse in the Randomized Phase [ Time Frame: Up to 24 weeks ]CIDP relapse, defined as an increase in modified Rankin Scale (mRS) of ≥ 1 point from baseline with resulting mRS ≥ 2, in the Randomized Phase.
- Percentage of subjects with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 52 weeks ]
- Rate of TEAEs per infusion [ Time Frame: Up to 52 weeks ]
- Rate of mild, moderate, and severe TEAEs per infusion [ Time Frame: Up to 52 weeks ]
- Percentage of subjects with serious TEAEs [ Time Frame: Up to 52 weeks ]
- Rate of serious TEAEs per infusion [ Time Frame: Up to 52 weeks ]
- Percentage of subjects with related TEAEs [ Time Frame: Up to 52 weeks ]
- Rate of related TEAEs per infusion [ Time Frame: Up to 52 weeks ]
- Percentage of subjects with CIDP relapse in the Dose Exploration Phase [ Time Frame: Up to 24 weeks ]
- Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase [ Time Frame: Up to 24 weeks ]

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Ages Eligible for Study: | 2 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects 2 to < 17 years of age with confirmed or possible CIDP and documentation of a clinical history of functional impairment due to CIDP, corresponding to an mRS score ≥ 2.
Exclusion Criteria:
- Absence of CIDP symptoms
- History or family history of inherited neuropathy
- Diagnosed developmental delay or regression
- History of thrombotic episode
- Known or suspected hypersensitivity to Privigen
- Known allergic or other severe reactions to blood products
- Female subject of childbearing potential either not using or not willing to use a medically reliable method of contraception or not sexually abstinent during the study
- Pregnant or breastfeeding mother"

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684018
Contact: Trial Registration Coordinator | 610-878-4000 | clinicaltrials@cslbehring.com |
United States, Arizona | |
Phoenix Children's Hospital | Recruiting |
Phoenix, Arizona, United States, 85016 | |
Contact: Use Central Contact | |
United States, California | |
University of California, San Francisco - Benioff Children's Hospital | Active, not recruiting |
San Francisco, California, United States, 94143 | |
United States, Florida | |
Nicklaus Children's Hospital | Active, not recruiting |
Miami, Florida, United States, 33155 | |
United States, Iowa | |
University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Use Central Contact | |
United States, Minnesota | |
Mayo Clinic | Active, not recruiting |
Rochester, Minnesota, United States, 55905 | |
United States, Ohio | |
Akron Children's Hospital | Recruiting |
Akron, Ohio, United States, 44647 | |
Contact: Use Central Contact | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Active, not recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15224 | |
Contact: Use Central Contact | |
United States, Virginia | |
Children's Specialty Group | Recruiting |
Norfolk, Virginia, United States, 23507 | |
Contact: Use Central Contact | |
Children's Hospital of Richmond | Active, not recruiting |
Richmond, Virginia, United States, 23298 | |
Canada, Alberta | |
Alberta Children's Hospital | Active, not recruiting |
Calgary, Alberta, Canada, T3B 6A8 | |
Canada, Ontario | |
Children's Hospital of Eastern Ontario | Active, not recruiting |
Ottawa, Ontario, Canada, K1H 8L1 | |
University of Toronto - The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Use Central Contact |
Study Director: | Study Director | CSL Behring |
Responsible Party: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT03684018 |
Other Study ID Numbers: |
IgPro10_4002 2018-003430-33 ( EudraCT Number ) |
First Posted: | September 25, 2018 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Polyradiculoneuropathy Autoimmune Diseases of the Nervous System |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Immunoglobulins, Intravenous Immunologic Factors Physiological Effects of Drugs |