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NCT02093221 · ClinicalTrials.gov registry record · Phase 2
Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
A Phase 2 study, sponsored by Grifols Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT02093221: Clinical Trial Phase 2 study, sponsored by Grifols Therapeutics.
NCT02093221 is a Phase 2 study that was terminated before completion, run by Grifols Therapeutics. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02093221, a Phase 2 study, was terminated before completion, sponsored by Grifols Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
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.
Primary Outcome
C-peptide concentration during MMTT with high protein energy drink. "Dose" for time frame refers to intake of high protein energy drink.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL 180 mg/kg Alpha1-PI
- BIOLOGICAL 90 mg/kg Alpha1-PI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
Why NCT02093221 stopped before completion
NCT02093221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02093221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02093221 about?
NCT02093221 is a clinical study titled "Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus". 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...
What is the current status of trial NCT02093221?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2014-03. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02093221?
The interventions under investigation include: Placebo (BIOLOGICAL), 180 mg/kg Alpha1-PI (BIOLOGICAL), 90 mg/kg Alpha1-PI (BIOLOGICAL).
Who is sponsoring clinical trial NCT02093221?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02093221's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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