Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency

Completed · Phase 3

Conditions studied: Primary Immunodeficiency

In brief

This study was designed to determine a dose of weekly subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%) that produces steady-state AUC of total IgG that was non-inferior to that of the regularly administered intravenous dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency subjects. This study was also designed to determine steady state trough total IgG levels after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety and tolerability of IGSC 20%.

Key facts

Study ID

NCT02604810

Run by

Grifols Therapeutics LLC

People needed

53

Starts

2016-01-01

Expected to finish

2017-12-01

Last updated by the study team

2019-10-04

Who can join

Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-existing diagnosis of primary immunodeficiency with features of hypogammaglobulinemia requiring IgG replacement therapy
• No serious bacterial infection within the last 3 months prior to or during Screening
• Currently on IgG replacement therapy (via IV or SC infusion) for ≥3 consecutive months. Subjects receiving IGIV must be receiving a dosage of 300 to 800 mg/kg per infusion
• Documented (at least once within previous 3 months) IgG trough level of ≥500 mg/dL on current IgG replacement therapy regimen

You may not qualify if…

• Known serious adverse reaction to immunoglobulin or any severe anaphylactic reaction to blood or any blood-derived product
• History of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study
• Isolated IgG subclass deficiency, isolated specific antibody deficiency disorder, or transient hypogammaglobulinemia of infancy
• Nephrotic syndrome, and/or a history of acute renal failure and/or severe renal impairment, and/or on dialysis
• History (year prior to Screening or 2 episodes in lifetime ) of or current diagnosis of deep venous thrombosis or thromboembolism (eg, deep vein thrombosis, myocardial infarction, cerebrovascular accident or transient ischemic attack)
• Acquired medical condition known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/μL [1.0 x 10\^9/L]), or human immunodeficiency virus infection/acquired immune deficiency syndrome
• Known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection
• Non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg in adult subjects)
• Receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents, (b) immunomodulators, (c) long-term systemic corticosteroids defined as daily dose >1 mg of prednisone equivalent/kg/day for>30 days Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a subject. Inhaled or topical corticosteroids are allowed.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• AIRE Medical of Los Angeles — Santa Monica, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Miami - Batchelor Children's Research Institute — Miami, Florida, United States
• Allergy Associates of The Palm Beaches, PA — North Palm Beach, Florida, United States
• University of South Florida — St. Petersburg, Florida, United States
• Emory Children's Center — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The South Bend Clinic — South Bend, Indiana, United States
• Children's Hospital of Michigan - Wayne State University — Detroit, Michigan, United States
• Midwest Immunology — Plymouth, Minnesota, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oklahoma Institute of Allergy and Asthma Clinical Research — Oklahoma City, Oklahoma, United States
• Vital Prospects Clinical Research Institute, PC — Tulsa, Oklahoma, United States
• Penn State University — Hershey, Pennsylvania, United States
• AARA Research Center — Dallas, Texas, United States
• Baylor Texas Children's Hospital — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Children's Hospital of Richmond at VCU, VCU Medical Center — Richmond, Virginia, United States
• Ottawa Hospital, Division of Infectious Disease and Respirology — Ottawa, Ontario, Canada
• CHU Sainte-Justine — Montreal, Quebec, Canada
• McGill University Health Center — Montreal, Canada
• Clinique d'asthme et d'allergie de Quebec — Québec, Canada
• The Hospital for Sick Children — Toronto, Canada

Full record on ClinicalTrials.gov

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