Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
NCT ID: NCT02093221
Last Updated: 2018-09-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
76 participants
INTERVENTIONAL
2014-03-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alpha1-PI 180 mg/kg/wk, 26 weeks
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks.
180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 weeks
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks.
90 mg/kg Alpha1-PI
Placebo, 26 weeks
Weekly infusions of placebo for 26 weeks.
Placebo
180 mg/kg/wk Alpha1-PI, 13 weeks
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks.
180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 weeks
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks
90 mg/kg Alpha1-PI
Placebo, 13 weeks
Weekly infusions of placebo for 13 weeks.
Placebo
Interventions
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180 mg/kg Alpha1-PI
90 mg/kg Alpha1-PI
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current use of injected insulin therapy and one positive result on testing for any of the following antibodies (If not currently on insulin therapy, must have positive result for at least two of the below antibodies):
* Anti-islet-cell antibodies (islet cell antigen 512, insulinoma associated protein 2),
* Anti-glutamic acid decarboxylase antibodies, or
* Anti-insulin antibodies (unless received insulin therapy for \> 7 days).
* Body Mass Index (BMI) ≤ 28 kg/m2 for adults (≥ 20 years of age) OR ≤ 90th percentile in accordance with the Centers for Disease Control BMI assessment for children and teens (2 through 19 years old).
Exclusion Criteria
* Known thrombophilia or history of thrombosis.
* Malignant disease (including malignant melanoma; however, other forms of skin cancer are allowed) within five years of randomization.
* Active Hepatitis A virus, Hepatitis B virus, Hepatitis C virus, or Human Immunodeficiency Virus infection.
* History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
* Known selective or severe Immunoglobulin A deficiency.
* Elevated liver enzymes (aspartate transaminase, alanine aminotransferase, and alkaline phosphatase) equal to or greater than 2.5 times the upper limit of normal.
* Therapy with exenatide or any other agents that stimulate pancreatic β cell regeneration or insulin secretion, or any antidiabetic agents (oral or parenteral) other than insulin within one month prior to screening.
* Use of omega-3 fatty acid supplements, including fish oil, within seven days prior to screening.
* Current or planned therapy with inhaled insulin, if it becomes available.
* Chronic use of systemic steroids, with the exception of inhaled steroids, above a stable dose equivalent to 5 mg/day prednisone (e.g., 10 mg every 2 days) within 4 weeks prior to randomization. It is recommended to maintain the same dose throughout the study. (Note: Subjects with autoimmune conditions (i.e., asthma) necessitating treatment with systemic short-term corticosteroids and administered a rapid taper are eligible per protocol with the caveat that the tapering is complete or decreased to the minimum requirement (i.e., 5 mg/day) at least 1 week prior to the Baseline visit (when randomization occurs) to ensure the subject is stable. For longer term steroid usage, please consult the Grifols Medical Monitor before considering the subject for study participation.)
* Treatment with immunosuppressants or cytostatic agents within 6 months of randomization.
6 Years
35 Years
ALL
No
Sponsors
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Grifols Therapeutics LLC
INDUSTRY
Responsible Party
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Locations
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University of Arizona
Tucson, Arizona, United States
Clinica Medica San Miguel
Los Angeles, California, United States
Diabetes Associates Medical Group
Orange, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Metabolic Institute of America
Tarzana, California, United States
Ronald H Chochinov MD
Ventura, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
Solutions Through Advanced Research Inc.
Jacksonville, Florida, United States
CCM Clinical Research
Miami, Florida, United States
Advanced Pharma CR LLC
Miami, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Cook County Hospital
Chicago, Illinois, United States
Methodist Research Institute
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Barry J. Reiner MD, LLC.
Baltimore, Maryland, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States
Women and Children's Hospital
Buffalo, New York, United States
WakeMed Children's Hospital
Raleigh, North Carolina, United States
Endocrinology Associates Inc
Columbus, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Pediatric Endocrinology, Genetics & Metabolism
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rapid City Regional Hospital/Health Clinical Research
Rapid City, South Dakota, United States
Research Institute of Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Consano Clinical Research
San Antonio, Texas, United States
Countries
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References
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Lagarde WH, Courtney KL, Reiner B, Steinmann K, Tsalikian E, Willi SM. Human plasma-derived alpha1 -proteinase inhibitor in patients with new-onset type 1 diabetes mellitus: A randomized, placebo-controlled proof-of-concept study. Pediatr Diabetes. 2021 Mar;22(2):192-201. doi: 10.1111/pedi.13162. Epub 2020 Dec 13.
Other Identifiers
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GTI1302
Identifier Type: -
Identifier Source: org_study_id
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