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Low-Dose ATG for Type 1 Diabetes (TN28 Trial)
TN28 Trial Summary
This trialtests if a drug can help prevent Type 1 diabetes from getting worse in people at risk.
TN28 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTN28 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 52 Patients • NCT00385788TN28 Trial Design
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- My hemoglobin levels are below the normal range for my age and gender.I have received or will receive the flu shot at least 2 weeks before joining the study.I am up to date on vaccinations and have no untreated health issues.You have had tuberculosis in the past or currently have tuberculosis.I am between 12 and 34 years old.I meet the criteria for early-stage diabetes and have high-risk markers.My autoimmune thyroid or celiac disease has been under control for the last 6 months.I have diabetes with two or more specific autoantibodies present.You have HIV, Hepatitis B, or Hepatitis C infection now or in the past.I have had cancer other than skin cancer in the past.I am using non-insulin diabetes medication.I meet the criteria for early-stage diabetes and have high-risk markers.It has been over 4 weeks since my last live vaccine.I am an adult fully vaccinated or a child on track with vaccinations per AAP guidelines.I agree not to get any vaccines, except for the flu shot, for 3 months after the study drug treatment.I am currently using immunosuppressive drugs or steroids regularly.My kidney function is not normal, as shown by my creatinine levels.My BMI is within the healthy range for my age.I have not received a live virus vaccine in the last 4 weeks.I am fully vaccinated against COVID-19, including boosters, and tested negative recently.My blood pressure is below 130/80 mmHg if I'm 18 or older, or below the 95th percentile for my age, sex, and height if I'm younger.Your bilirubin levels are higher than normal, unless you have been diagnosed with Gilbert's Disease.Your liver function tests show abnormal levels of AST or ALT.I do not have symptoms of an active infection, including COVID-19.I have a weak immune system or low blood cell counts.I have tested negative for CMV and EBV in the last 30 days and haven't had symptoms of these viruses for more than 7 days.I do not have heart, lung, blood, or neurological conditions that could affect the study.I have previously been treated with Teplizumab.I was diagnosed with Stage 3 Type 1 Diabetes.I am willing to give my consent, or my guardian will if I'm under 18.I was in a diabetes prevention trial and got the treatment less than 3 months ago.I have been treated with ATG or am allergic to rabbit products.You have had bad reactions to heparin before.I live or can stay close to the treatment center and a hospital for 3 days during my treatment.You are allergic to ATG.My weight is above the 5th percentile for my age and sex.
- Group 1: Antithymocyte globulin (ATG)
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Antithymocyte globulin (ATG) as a viable medical treatment?
"Patient safety is a top priority for our team at Power, and after carefully assessing the clinical data available, we rated Antithymocyte globulin (ATG) with a score of 2. This was due to Phase 2 trial findings which suggested some safety but no efficacy."
What maladies does Antithymocyte globulin (ATG) typically address?
"Antithymocyte globulin (ATG) can aid in the treatment of acute renal rejection, myelodysplastic syndrome, and immunosuppressive therapy."
Does this research accommodate participants younger than 20 years old?
"As stated in the inclusion criteria, participants between 12 and 34 years old are eligible for this trial. For those younger than twelve or older than 65, there are 178 studies and 197 trials respectively that may be suitable."
Are there any other studies that have investigated the effects of Antithymocyte globulin (ATG)?
"Currently, 54 medical studies are underway for the drug Antithymocyte globulin (ATG), with 7 trials in Phase 3. The vast majority of these clinical investigations are occurring at a research centre located in Gainesville, Florida; yet there is additional activity across 347 different sites nationwide."
Are there vacant slots available to participate in this experiment?
"That is accurate. According to clinicaltrials.gov, this medical trial was initially listed on January 1st 2023 and recently revised on May 1st of the same year. The study requires 114 people over a single location in order to move forward."
How many participants are currently enlisted in this trial?
"Affirmative, clinicaltrials.gov confirms that this medical research is currently enrolling participants. The trial was first published on January 1st 2023 and has been updated as recently as May 1st of the same year. To date, 114 individuals have been recruited from a single site to participate in the study."
Am I eligible to take part in this investigative work?
"This trial seeks to enrol 114 individuals between 12 and 34 with type 1 diabetes. Candidates need to satisfy specific requirements, such as having 2 or more applicable autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A), a body mass index within the 5th percentile for their age group (if under 18) or <30 if an adult (<18 years old), HbA1c ≥5.7 yet <6.5%, DPTRS ≥ 7.4; dysglycemia must be present in some form, being 4 weeks away from receiving any live"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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