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NCT01183468 · ClinicalTrials.gov registry record · Phase 1
A Research Trial of Aralast in New Onset Diabetes (RETAIN)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01183468: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01183468 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01183468, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to injuries) that affects the cells thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D). All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD) and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in Part II (NCT01183455, Phase II Clinical Trial) will begin.
Primary Outcome
No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.
Interventions
- BIOLOGICAL Aralast NP 45 mg dose
- BIOLOGICAL Aralast NP 90 mg dose
- BIOLOGICAL Aralast NP 180 mg dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
Why NCT01183468 stopped before completion
NCT01183468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Aralast NP 45 mg dose is the first listed.
NCT01183468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01183468 about?
NCT01183468 is a clinical study titled "A Research Trial of Aralast in New Onset Diabetes (RETAIN)". The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to injuries) that affects the cells thought to be involved in the development...
What is the current status of trial NCT01183468?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2010-10. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01183468?
The interventions under investigation include: Aralast NP 45 mg dose (BIOLOGICAL), Aralast NP 90 mg dose (BIOLOGICAL), Aralast NP 180 mg dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT01183468?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01183468's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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