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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03428945




Registration number
NCT03428945
Ethics application status
Date submitted
24/01/2018
Date registered
12/02/2018
Date last updated
9/04/2024

Titles & IDs
Public title
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
Scientific title
Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)
Secondary ID [1] 0 0
UC4DK117009
Secondary ID [2] 0 0
Hydroxychloroquine
Universal Trial Number (UTN)
Trial acronym
TN-22
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type1 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Hydroxychloroquine
Treatment: Drugs - Placebo

Experimental: Hydroxychloroquine - Hydroxychloroquine compound for oral use

Placebo Comparator: Placebo - Placebo tablet matching active drug


Treatment: Drugs: Hydroxychloroquine
Hydroxychloroquine for oral administration, dosed by weight

Treatment: Drugs: Placebo
Placebo tablet identical to active drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes
Timepoint [1] 0 0
Glucose tolerance is measured every 6 months for up to 4 years

Eligibility
Key inclusion criteria
1. Participant in TrialNet Pathway to Prevention Study (TN01)

2. Age 3 years or greater at the time of randomization

3. Willing to provide informed consent

4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline

5. Two or more diabetes-related autoantibodies present on two separate samples

6. Weight of 12 kg or greater at screening

7. If a female participant with reproductive potential, willing to avoid pregnancy and
undergo pregnancy testing prior to randomization and at each study visit

8. Anticipated ability to swallow study medication.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Abnormal Glucose Tolerance or Diabetes

2. History of treatment with insulin or other diabetes therapies

3. Ongoing use of medications known to influence glucose tolerance

4. Ongoing or anticipated future use of medications known to have untoward interactions
with hydroxychloroquine

5. Known hypersensitivity to 4-aminoquinoline compounds

6. G6PD deficiency

7. History of retinopathy

8. Have an active infection at time of randomization

9. Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B
core antibody or surface antigen), or Hepatitis C infection

10. 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.

11. 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.

12. Be pregnant or breastfeeding.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2022
Sample size
Target
Accrual to date
Final
273
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Women's and Children's Hospital, Adelaide - North Adelaide
Recruitment hospital [3] 0 0
Walter and Eliza Hall Institute of Medical Research - Parkville
Recruitment hospital [4] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6840 - Perth
Recruitment outside Australia
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nevada
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New York
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Canada
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Ontario
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Canada
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Halifax
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Italy
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Milan
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Sweden
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Malmö
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United Kingdom
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Devon
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United Kingdom
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North Yorkshire
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United Kingdom
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UK
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United Kingdom
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Nottingham

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Juvenile Diabetes Research Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03428945
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carla Greenbaum, MD
Address 0 0
Type 1 Diabetes TrialNet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03428945