Status:
TERMINATED
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type1 Diabetes Mellitus
Eligibility:
All Genders
3+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This study is testing a medication, called hydroxychloroquine (HCQ) to assess safety and effectiveness to prevent individuals at risk of type 1 diabetes (T1D) from progressing to type 1 diabetes. HCQ...
Eligibility Criteria
Inclusion
- Participant in TrialNet Pathway to Prevention Study (TN01)
- Age 3 years or greater at the time of randomization
- Willing to provide informed consent
- Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline
- Two or more diabetes-related autoantibodies present on two separate samples
- Weight of 12 kg or greater at screening
- If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit
- Anticipated ability to swallow study medication.
Exclusion
- Abnormal Glucose Tolerance or Diabetes
- History of treatment with insulin or other diabetes therapies
- Ongoing use of medications known to influence glucose tolerance
- Ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine
- Known hypersensitivity to 4-aminoquinoline compounds
- G6PD deficiency
- History of retinopathy
- Have an active infection at time of randomization
- Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection
- Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
- Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
- Be pregnant or breastfeeding.
Key Trial Info
Start Date :
August 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT03428945
Start Date
August 15 2018
End Date
October 31 2022
Last Update
April 9 2024
Active Locations (51)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of California - San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Barbara Davis Center
Aurora, Colorado, United States, 80045