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NCT04118153 · ClinicalTrials.gov registry record · Early Phase 1
Early Markers of Disease and Response to Therapy
A Early Phase 1 study of Type 1 Diabetes, sponsored by Sandra Lord, MD.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT04118153: Completed Early Phase 1 study of Type 1 Diabetes, sponsored by Sandra Lord, MD.
NCT04118153 is a Early Phase 1 study of Type 1 Diabetes that has completed, run by Sandra Lord, MD. The registered enrollment target is 60 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04118153, a Early Phase 1 study of Type 1 Diabetes, has completed, sponsored by Sandra Lord, MD.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, participants who were recently diagnosed with T1D (males or females, ages 6-45 and \<7months from T1D diagnosis) will be treated with a short-course of abatacept (weekly subcutaneous injections for 3 months). Participants will undergo baseline and repeated mixed meal tolerance testing (MMTT) to assess disease progression and blood samples will be obtained at frequent intervals to measure changes in immune markers.
Primary Outcome
Insulin antibody titers
Conditions Studied
Interventions
- DRUG Abatacept
Study Locations (2)
Washington
- Benaroya Research Institute - Seattle
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2024-05-24 |
| Phase | Early Phase 1 |
What the finished NCT04118153 record still lists
NCT04118153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Abatacept is the first listed.
NCT04118153 reports a single indexed study location in Washington, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04118153 about?
NCT04118153 is a clinical study titled "Early Markers of Disease and Response to Therapy". The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, participants who were recently diagnosed with T1D (males or females, ages 6-45 and \<7months from T1D di...
What is the current status of trial NCT04118153?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2021-03-05. Estimated completion is 2024-05-24.
What conditions does trial NCT04118153 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT04118153?
The interventions under investigation include: Abatacept (DRUG).
Who is sponsoring clinical trial NCT04118153?
This trial is sponsored by Sandra Lord, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04118153 being conducted?
This trial has 2 study locations across Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
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 NCT04118153's enrollment target sits among peer trials
60 73rd of 198 higher than 117 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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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