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NCT02215200 · ClinicalTrials.gov registry record · Phase 2
ATG-GCSF in New Onset Type 1 Diabetes
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
NCT02215200 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 89 participants.
The verdict
NCT02215200, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
Study Summary
This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D). The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.
Interventions
- DRUG Anti-Thymocyte Globulin (ATG)
- DRUG Granulocyte colony stimulating factor (GCSF)
- DRUG Placebo (for ATG)
- DRUG Placebo (for GCSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02215200
The ClinicalTrials.gov registry entry for NCT02215200 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Anti-Thymocyte Globulin (ATG) is the first listed.
NCT02215200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02215200 about?
NCT02215200 is a clinical study titled "ATG-GCSF in New Onset Type 1 Diabetes". This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo a...
What is the current status of trial NCT02215200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2014-12. Estimated completion is 2018-08.
What interventions are being tested in trial NCT02215200?
The interventions under investigation include: Anti-Thymocyte Globulin (ATG) (DRUG), Granulocyte colony stimulating factor (GCSF) (DRUG), Placebo (for ATG) (DRUG), Placebo (for GCSF) (DRUG).
Who is sponsoring clinical trial NCT02215200?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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