A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II
Public ClinicalTrials.gov record NCT01183455. 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
Effect of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus (ITN041AI)- Part II
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug to be tested in this clinical trial. Aralast NP is an anti-inflammatory drug that affects the cells that are thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D). This study, known as RETAIN, was planned as a two-part trial to investigate the effect of Aralast NP on preserving beta cell function and to determine if the intervention would slow the progression of type 1 diabetes. Part I of this trial (NCT 01183468) was an open-label, safety and dose level study consisting of two groups. After completion of Part I, including a satisfactory safety review, enrollment in Part II was to begin. Part II was designed as a two-arm, double-blind, placebo-controlled clinical trial, and participants were to be randomly assigned to either the Aralast NP treatment or placebo group.
Study identification
- NCT ID
- NCT01183455
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 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
- Oct 2010 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Aug 2014 (Actual)
- Last update posted
- Dec 31, 2014
2010 – 2014
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | — |
| Barbara Davis Center | Aurora | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06511 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Calvert Memorial Hospital | Prince Frederick | Maryland | 20678 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| University of Massachusetts Medical School | Worchester | Massachusetts | 01655 | — |
| Columbia University | New York | New York | 10027 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| The Children's Hospital of Philadelphia | Philadephia | Pennsylvania | 19104 | — |
| Cetero Research San Antonio | San Antonio | Texas | 78229 | — |
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 NCT01183455, 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 Dec 31, 2014 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01183455 live on ClinicalTrials.gov.