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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 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 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states.

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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.

Conditions Studied

Interventions

  • DRUG Abatacept

Study Locations (2)

Washington

  • Benaroya Research Institute - Seattle

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-03-05
Est. Completion 2024-05-24
Phase Early Phase 1

Sponsor

Sandra Lord, MD

1 total trials

What the Registry Record Tells You About NCT04118153

The ClinicalTrials.gov registry entry for NCT04118153 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The listed sponsor is Sandra Lord, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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