Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT02093221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Partial-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM). Currently enrolling ages 12-35 only. Once 25 patients are randomized and data is reviewed enrollment will be opened to the child cohort. The purpose of this study is to evaluate the safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.
Study identification
- NCT ID
- NCT02093221
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Interventions
- 180 mg/kg Alpha1-PI Biological
- 90 mg/kg Alpha1-PI Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Years to 35 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2014 (Type not available)
- Primary completion
- Jan 2017 (Actual)
- Completion
- Jun 2017 (Actual)
- Last update posted
- Sep 5, 2018
2014 – 2017
United States locations
- U.S. sites
- 36
- U.S. states
- 24
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | — |
| Clinica Medica San Miguel | Los Angeles | California | 90015 | — |
| Diabetes Associates Medical Group | Orange | California | 92868 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | — |
| Metabolic Institute of America | Tarzana | California | 91356 | — |
| Ronald H Chochinov MD | Ventura | California | 93003 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06511 | — |
| Christiana Care Health Services | Newark | Delaware | 19713 | — |
| Solutions Through Advanced Research Inc. | Jacksonville | Florida | 32258 | — |
| CCM Clinical Research | Miami | Florida | 33133 | — |
| Advanced Pharma CR LLC | Miami | Florida | 33136 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | — |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | — |
| Cook County Hospital | Chicago | Illinois | 60612 | — |
| Methodist Research Institute | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Barry J. Reiner MD, LLC. | Baltimore | Maryland | 21229 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | 55102 | — |
| Morristown Medical Center | Morristown | New Jersey | 07962 | — |
| University of New Mexico, Health Sciences Center | Albuquerque | New Mexico | 87131-0001 | — |
| Women and Children's Hospital | Buffalo | New York | 14222 | — |
| WakeMed Children's Hospital | Raleigh | North Carolina | 27610 | — |
| Endocrinology Associates Inc | Columbus | Ohio | 43201 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Pediatric Endocrinology, Genetics & Metabolism | Oklahoma City | Oklahoma | 73112 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19106 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Rapid City Regional Hospital/Health Clinical Research | Rapid City | South Dakota | 57701 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Northeast Clinical Research of San Antonio LLC | San Antonio | Texas | 78154 | — |
| University of Texas Health Science Center | San Antonio | Texas | 78229 | — |
| Consano Clinical Research | San Antonio | Texas | 78232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02093221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 5, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02093221 live on ClinicalTrials.gov.