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Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

NCT03428945 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2024-04-09

Study results available
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Summary

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.

Conditions

  • Type1 Diabetes Mellitus

Interventions

DRUG

Hydroxychloroquine

Hydroxychloroquine for oral administration, dosed by weight

DRUG

Placebo

Placebo tablet identical to active drug

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Carla Greenbaum, MD · Type 1 Diabetes TrialNet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2022-10-27
Completion
2022-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428945 on ClinicalTrials.gov