1. Immune globulin subcutaneous, human – klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study
- Author
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William R. Lumry, James B Harris, Jiang Lin, Elsa Mondou, Kecia L. Courtney, John W. Sleasman, Mark R. Stein, H. James Wedner, and I. Hussain
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Immunology ,Bioequivalence ,Infusions, Subcutaneous ,Gastroenterology ,Young Adult ,Pharmacokinetics ,Internal medicine ,Humans ,Immunology and Allergy ,Medicine ,Prospective Studies ,Child ,Trial registration ,Adverse effect ,Immunodeficiency ,Aged ,biology ,business.industry ,Immunologic Deficiency Syndromes ,Immunoglobulins, Intravenous ,Middle Aged ,medicine.disease ,Treatment Outcome ,Therapeutic Equivalency ,Oncology ,Tolerability ,Child, Preschool ,Immunoglobulin G ,biology.protein ,Female ,Open label ,Antibody ,business - Abstract
Aim: This prospective, Phase III study assessed the pharmacokinetics (PK), safety and tolerability of immune globulin subcutaneous, human – klhw 20% solution (IGSC-C 20%) in participants with primary humoral immunodeficiency (PI), compared with immune globulin injection (human), 10% caprylate/chromatography purified (IGIV-C 10%). Patients & methods: About 53 participants enrolled. Total 44 received IGIV-C 10% in the run-in phase and then entered the IV phase (with an additional nine who were already receiving IGIV-C 10% and entered the IV phase directly) for steady-state IV PK assessments. Total 49 entered the SC phase (weekly doses of IGSC-C 20% for ∼24 weeks). The PK profiles of IGIV-C 10% and IGSC-C 20% and their safety and tolerability parameters were compared. Results: At a dose adjustment factor of 1.37, IGSC-C 20% provided comparable (noninferior and bioequivalent) overall total immunoglobulin G exposure to IGIV-C 10% over an equal time interval. About 33 participants reported 79 adverse events during run-in + IV phases; 41 participants reported 141 adverse events during the SC phase, with most being local infusion site reactions. The majority of infusion site reactions were mild to moderate in severity. Conclusion: IGSC-C 20% was bioequivalent to IGIV-C 10% and was well tolerated, with a safety profile comparable with IGIV-C 10%, in this study. Trial registration: ClinicalTrials.gov identifier: NCT02604810 more...
- Published
- 2019
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