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NCT03929601 · ClinicalTrials.gov registry record · Phase 2
Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Active
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 19
- Study locations
NCT03929601: Active Phase 2 study of Type 1 Diabetes Mellitus, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT03929601 is a Phase 2 study of Type 1 Diabetes Mellitus that is active but no longer recruiting, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 74 participants, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (57% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03929601, a Phase 2 study of Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 19
- Study locations
Study Summary
The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.
Primary Outcome
The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab compared to those participants treated with Rituximab and placebo 24 months after enrollment.
Conditions Studied
Interventions
- DRUG Abatacept
- DRUG Rituximab-pvvr
- DRUG Sterile Sodium Chloride
Study Locations (19)
California
- Childrens Hospital of Orange County - Orange
- Stanford University - Palo Alto
- University of California San Francisco - San Francisco
Florida
- University of Florida - Gainesville
- University of Miami - Maimi
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
Connecticut
- Yale University - New Haven
Indiana
- Indiana University - Riley Hospital for Children - Indianapolis
Kansas
- The Children's Mercy Hospital - Kansas City
Massachusetts
- Joslin Diabetes Center - Boston
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-10-30 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 2 |
What the registry record for NCT03929601 still lists
NCT03929601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Abatacept is the first listed.
NCT03929601 lists 19 locations in 16 states (California, Florida, Colorado).
Frequently Asked Questions
What is clinical trial NCT03929601 about?
NCT03929601 is a clinical study titled "Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes". The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improve...
What is the current status of trial NCT03929601?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2023-10-30. Estimated completion is 2029-03-31.
What conditions does trial NCT03929601 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03929601?
The interventions under investigation include: Abatacept (DRUG), Rituximab-pvvr (DRUG), Sterile Sodium Chloride (DRUG).
Who is sponsoring clinical trial NCT03929601?
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.
Where is trial NCT03929601 being conducted?
This trial has 19 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03929601's enrollment target sits among peer trials
74 39th of 112 higher than 74 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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.
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