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CFZ533 for Type 1 Diabetes (CCFZ533X2207 Trial)
CCFZ533X2207 Trial Summary
This trialwill study how a drug can help preserve diabetes in kids and young adults.
CCFZ533X2207 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCCFZ533X2207 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CCFZ533X2207 Trial Design
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Who is running the clinical trial?
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- You have tested positive for HIV at screening.I am not on any medications that the study does not allow.I can start the study drug within 56 to 100 days of my type 1 diabetes diagnosis.I haven't had major dental work or a fever in the last 8 days.Your blood tests must show normal levels of white blood cells, neutrophils, lymphocytes, hemoglobin, and platelets. You should not have a history of immune system disorders or frequent infections that suggest a weak immune system.I do not have active Hepatitis B or C.I have received all necessary vaccines according to local guidelines before starting the study drug.You cannot be taking experimental drugs or certain medications that weaken the immune system within a certain period before joining the study.I have not had any cancer, other than skin cancer, in the last 5 years.My C-peptide levels are adequate based on a recent test.You have a history of drug abuse, heavy alcohol use, or nicotine use within the last year. This includes drinking five or more drinks per day for five or more days in the past month. Any use of alcohol by children (ages 6-12) is not allowed. The decision about harmful cannabinoid use will be made by the study doctor based on local laws and customs.I am using effective birth control or am not of childbearing potential.I have a blood clotting disorder that increases my risk of clots.You have had a serious allergic reaction to biological drugs in the past.I have been using medications that can affect my blood sugar levels, except for a short course of oral steroids.I have not had diabetic ketoacidosis in the last 2 weeks.I have tested positive for one or more type 1 diabetes autoantibodies.I have an autoimmune condition like Addison's, pernicious anemia, or celiac disease.I have a positive TB test but no active tuberculosis, or I am treated for latent TB.I have a form of diabetes that is not type 1.I have a recent infection shown by high viral load or positive IgM without IgG.You have a serious mental illness that is currently being treated by a psychiatrist, like eating disorders or psychosis.My weight is between 20 and 125 kg.I am between 6 and 21 years old.I have taken a pregnancy test and it was negative.You have a history of many allergies, especially to the investigational drug being used in the study. Allergies to common things like dust mites and hay fever are okay.
- Group 1: Placebo
- Group 2: CFZ533
- 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
Am I eligible to be a volunteer in this experiment?
"This medical experiment is recruiting 102 participants between the ages of 6 and 21 who have type 1 diabetes mellitus. In order to be eligible, these criteria must be met."
Has CFZ533 satisfied the Food and Drug Administration's criteria for approval?
"Despite being in Phase 2, and thus lacking clinical evidence of efficacy, our team at Power has assigned CFZ533 a safety rating of 2 due to available data suggesting its harmlessness."
What is the total number of participants involved in this clinical trial?
"Affirmative. The clinical trial is presently seeking participants, as evidence on clinicaltrials.gov shows that it was first posted on 8th November 2019 and last updated 10th November 2022. It aims to recruit 102 patients from two separate sites."
Does the study have an age minimum to qualify as a participant?
"This trial's specified eligibility requirements state that it is open to individuals between 6 and 21 years old. Clinicialtrials.gov indicates that there are 220 studies recruiting patients younger than 18 and 922 studying those aged 65 or more."
Is enrollment open for this clinical investigation?
"Affirmative. Clinicaltrials.gov data indicates that this research effort, initially posted on November 8th 2019, is actively recruiting individuals to participate in the trial. A total of 102 patients must be enrolled from two different locations."
Has CFZ533 been subject to any other research trials?
"Currently, there are 3 active trials studying the effects of CFZ533 with no studies in their final phase. Primarily located in Munich, Bavaria, these investigations into this medication has spread to 150 other sites worldwide."
Does this research constitute a pioneering effort?
"Presently, Novartis Pharmaceuticals is sponsoring 3 separate clinical trials on CFZ533 across 47 cities and 26 countries. Initially launching in 2019, the Phase 2 drug approval trial consisted of 273 participants; since then, a further 18325 studies have been conducted."
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