Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-01-28 @ 5:50 PM
Study NCT ID:
NCT03684018
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2018-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Dose Levels of Privigen in Pediatric CIDP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level', 'timeFrame': 'Approximately 24 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level', 'timeFrame': 'Approximately 56 weeks'}, {'measure': 'Rate of TEAEs per infusion', 'timeFrame': 'Approximately 56 weeks'}, {'measure': 'Rate of mild, moderate, and severe TEAEs per infusion by dose level', 'timeFrame': 'Approximately 56 weeks'}, {'measure': 'Percentage of subjects with serious TEAEs', 'timeFrame': 'Approximately 56 weeks'}, {'measure': 'Rate of serious TEAEs per infusion', 'timeFrame': 'Approximately 56 weeks'}, {'measure': 'Percentage of subjects with related TEAEs', 'timeFrame': 'Approximately 56 weeks'}, {'measure': 'Rate of related TEAEs per infusion', 'timeFrame': 'Approximately 56 weeks'}, {'measure': 'Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase', 'timeFrame': 'Approximately 24 weeks'}, {'measure': 'Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase', 'timeFrame': 'Baseline and Approximately 24 weeks', 'description': 'The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death)'}, {'measure': 'Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level', 'timeFrame': 'Approximately 24 weeks', 'description': 'CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit'}, {'measure': 'Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level', 'timeFrame': 'Approximately 24 weeks', 'description': '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'}, {'measure': 'Time to CIDP relapse in Randomized Phase by dose level', 'timeFrame': 'Approximately 24 weeks'}, {'measure': 'Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level', 'timeFrame': 'Approximately 24 weeks', 'description': 'CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline'}, {'measure': 'Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level', 'timeFrame': 'Approximately 24 weeks', 'description': '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'}, {'measure': 'Time to CIDP Relapse in the Dose Exploration Phase by dose level', 'timeFrame': 'Approximately 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)']}, 'referencesModule': {'references': [{'pmid': '38353301', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.\n\nExclusion Criteria:\n\n* \\- Absence of CIDP symptoms\n* -History or family history of inherited neuropathy\n* -Diagnosed developmental delay or regression\n* -History of thrombotic episode\n* -Known or suspected hypersensitivity to Privigen\n* -Known allergic or other severe reactions to blood products\n* -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\n* -Pregnant or breastfeeding mother"'}, 'identificationModule': {'nctId': 'NCT03684018', 'briefTitle': 'Two Dose Levels of Privigen in Pediatric CIDP', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP', 'orgStudyIdInfo': {'id': 'IgPro10_4002'}, 'secondaryIdInfos': [{'id': '2018-003430-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IgPro10 (dose level 1)', 'interventionNames': ['Biological: IgPro10']}, {'type': 'EXPERIMENTAL', 'label': 'IgPro10 (dose level 2)', 'interventionNames': ['Biological: IgPro10']}], 'interventions': [{'name': 'IgPro10', 'type': 'BIOLOGICAL', 'otherNames': ['Privigen'], 'description': 'Normal human immunoglobulin G administered intravenously', 'armGroupLabels': ['IgPro10 (dose level 1)', 'IgPro10 (dose level 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '52242-1009', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '44647', 'city': 'Akron', 'state': 'Ohio', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Use Central Contact', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': "Le Bonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '76208', 'city': 'Denton', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Use Central Contact', 'role': 'CONTACT'}], 'facility': 'Neurology Rare Disease Center', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Children's Specialty Group", 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Use Central Contact', 'role': 'CONTACT'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Trial Registration Coordinator', 'role': 'CONTACT', 'email': 'clinicaltrials@cslbehring.com', 'phone': '+1 610-878-4697'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}