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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 is a Phase 2 study that was terminated before completion, run by Grifols Therapeutics. The registered enrollment target is 76 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02093221
The ClinicalTrials.gov registry entry for NCT02093221 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02093221 reports 0 study locations.
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.
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