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Hydroxychloroquine (Plaquenil) Starts a Phase-II? Trial To Prevent Type-1 In Presymptomatics

Discussion in 'Research' started by joshualevy, Dec 23, 2018.

  1. joshualevy

    joshualevy Approved members

    Joined:
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    This study is testing a medication, called hydroxychloroquine (HCQ) to assess safety and effectiveness to prevent individuals at risk of type 1 diabetes from progressing to type 1 diabetes.

    HCQ is approved by the U.S. Food and Drug Administration as a treatment (not a cure) for malaria, lupus, and rheumatoid arthritis. It operates through several pathways, including as an anti-inflammatory. HCQ has been used for over 60 years, but has not previously been studied as a treatment to prevent T1D.

    This Study

    These researchers are recruiting 200 people who are at least 3 years old and test positive for 2 or more autoantibodies as part of TrialNet. 2/3s will get the drug and 1/3 will get a placebo and will be a control group. The study involves 5 visits in the first 6 months, then 1 visit every 6 months for the remainder of the study (about six years).

    The primary end point is the number of people who progress to having abnormal blood glucose numbers or to being diagnosed with type-1 diabetes. (The hope is that few people getting the treatment will make this progression, as compared to the placebo group.) The study started in Aug-2018 and they hope to finish in 2024. Prevention studies take a long time, because the onset of type-1 takes a long time, so the researchers need to wait a long time to see if fewer people get the disease.

    This trial is part of TrialNet and is being funded by JDRF.

    The study's web page is here: https://www.trialnet.org/our-research/prevention-studies/hydroxychloroquine-hcq

    This study is recruiting at several sites all over the US:

    Barbara Davis Center: Aurora, Colorado, United States, 80045
    Contact: Betsy Burke 303-724-6766 Betsy.Burke@ucdenver.edu
    Principal Investigator: Andrea Steck, MD

    University of Florida: Gainesville, Florida, United States, 32610
    Contact: Jennifer Hosford 352-294-5759 jennifer.hosford@medicine.ufl.edu
    Contact: Paula Towe 352-294-5761 pdtowe@peds.ufl.edu
    Principal Investigator: Desmond Schatz, MD

    University of Miami: Miami, Florida, United States, 33136
    Contact: Della Matheson 305-243-3781 dmatheso@med.miami.edu
    Contact: Natalia Sanders-Branca 305-243-6616 n.sanders1@med.miami.edu
    Principal Investigator: David Baidal, MD

    University of Pittsburgh: Pittsburgh, Pennsylvania, United States, 15224
    Contact: David Groscost 412-692-7241 david.groscost@chp.edu
    Contact: Kelli Delallo 412-692-5210 kelli.delallo@chp.edu
    Principal Investigator: Dorothy Becker, MD

    Vanderbilt Eskind Diabetes Clinic: Nashville, Tennessee, United States, 37232
    Contact: Brenna Dixon 615-337-9597 brenna.dixon@vanderbilt.edu
    Contact: Faith Brendle 615-936-8638 faith.brendle@vanderbilt.edu
    Principal Investigator: William Russell, MD

    University of Texas Southwestern Recruiting
    Dallas, Texas, United States, 75390
    Contact: Lauren Boyles 241-648-4717 lauren.boyles@utsouthwestern.edu
    Principal Investigator: Philip Raskin, MD

    Benaroya Research Institute: Seattle, Washington, United States, 98101
    Contact: Mary Ramey 206-342-6945 mramey@benaroyaresearch.org
    Contact: Marli McCulloch-Olson 206-515-5239 Marli@benaroyaresearch.org
    Principal Investigator: Carla Greenbaum, MD

    Wikipedia on HCQ: https://en.wikipedia.org/wiki/Hydroxychloroquine
    Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT03428945

    Case studies:
    * https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4206615/
    * https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3029247

    Use in Type-2:
    * https://www.researchgate.net/publication/270282245_Ipca_gets_first_approval_for_HCQ_in_diabetes



    Joshua Levy
    http://cureresearch4type1diabetes.blogspot.com
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
     

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