Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency
An Open-label, Multi-center Study to Evaluate the Safety and Pharmacokinetics of IGSC 20% Administered for 6 Months in Subjects With Primary Immunodeficiency
1 other identifier
interventional
53
2 countries
25
Brief Summary
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2016
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
October 4, 2019
CompletedOctober 4, 2019
September 1, 2018
1.7 years
November 6, 2015
September 13, 2019
September 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
AUC in the IV Phase and SC Phases: Steady-state AUC of Total IgG Over a Regular Dosing Interval
The primary PK endpoint (steady-state AUC values) analysis was performed using analysis of variance (ANOVA) using PK data from a total of 49 subjects from the IV phase and 39 subjects from the SC phase.
For intravenous infusion, predose, 0,1,3-16 hours and 1,2,3,5,7,14,21 or 28 days (2, 7, 21, or 28 days for pediatric subjects) post-dose and for subcutaneous infusion, pre-dose,1,3,4,5,7 days (3 and 7 days for pediatric subjects) post-dose
Secondary Outcomes (1)
Mean Steady-state Trough (Pre-dose) Concentration of Total IgG Following IV Administration of IGIV-C 10% or SC Administration of IGSC 20%
For intravenous infusion, pre-dose at Week 1 and Week 3 or Week 4 and for subcutaneous infusion, predose at Weeks 13, 14, 17, and 21
Study Arms (2)
IGIV-C 10%
ACTIVE COMPARATORIV dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols)
IGSC 20%
EXPERIMENTALImmune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols)
Interventions
IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen
IGSC 20% weekly infusions with dose calculated based on previous IgG regimen
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
UCLA Medical Center
Los Angeles, California, 90095, United States
AIRE Medical of Los Angeles
Santa Monica, California, 90404, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Miami - Batchelor Children's Research Institute
Miami, Florida, 33136, United States
Allergy Associates of The Palm Beaches, PA
North Palm Beach, Florida, 33408, United States
University of South Florida
St. Petersburg, Florida, 33701, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
Children's Hospital of Michigan - Wayne State University
Detroit, Michigan, 48201, United States
Midwest Immunology
Plymouth, Minnesota, 55446, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, 73131, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136, United States
Penn State University
Hershey, Pennsylvania, 17033, United States
AARA Research Center
Dallas, Texas, 75231, United States
Baylor Texas Children's Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Children's Hospital of Richmond at VCU, VCU Medical Center
Richmond, Virginia, 23298, United States
Ottawa Hospital, Division of Infectious Disease and Respirology
Ottawa, Ontario, K1H 8L6, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C4, Canada
McGill University Health Center
Montreal, H4A 3J1, Canada
Clinique d'asthme et d'allergie de Quebec
Québec, G1V 4M6, Canada
The Hospital for Sick Children
Toronto, M5G 1X8, Canada
Related Publications (1)
Sleasman JW, Lumry WR, Hussain I, Wedner HJ, Harris JB, Courtney KL, Mondou E, Lin J, Stein MR. Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study. Immunotherapy. 2019 Nov;11(16):1371-1386. doi: 10.2217/imt-2019-0159. Epub 2019 Oct 17.
PMID: 31621458DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rhonda Griffin
- Organization
- Grifols Therapeutics LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2015
First Posted
November 13, 2015
Study Start
January 1, 2016
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
October 4, 2019
Results First Posted
October 4, 2019
Record last verified: 2018-09