Sunday, December 23, 2018
Hydroxychloroquine (Plaquenil) Starts a Phase-II? Trial To Prevent Type-1 In Presymptomatics
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.
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 email@example.com
Contact: Paula Towe 352-294-5761 firstname.lastname@example.org
Principal Investigator: Desmond Schatz, MD
University of Miami: Miami, Florida, United States, 33136
Contact: Della Matheson 305-243-3781 email@example.com
Contact: Natalia Sanders-Branca 305-243-6616 firstname.lastname@example.org
Principal Investigator: David Baidal, MD
University of Pittsburgh: Pittsburgh, Pennsylvania, United States, 15224
Contact: David Groscost 412-692-7241 email@example.com
Contact: Kelli Delallo 412-692-5210 firstname.lastname@example.org
Principal Investigator: Dorothy Becker, MD
Vanderbilt Eskind Diabetes Clinic: Nashville, Tennessee, United States, 37232
Contact: Brenna Dixon 615-337-9597 email@example.com
Contact: Faith Brendle 615-936-8638 firstname.lastname@example.org
Principal Investigator: William Russell, MD
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Lauren Boyles 241-648-4717 email@example.com
Principal Investigator: Philip Raskin, MD
Benaroya Research Institute: Seattle, Washington, United States, 98101
Contact: Mary Ramey 206-342-6945 firstname.lastname@example.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
Use in Type-2:
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.