Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01183468
The ClinicalTrials.gov registry entry for NCT01183468 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Aralast NP 45 mg dose is the first listed.
NCT01183468 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.