Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children aged 6 to 16 years old.
• Children whose body weight and height fall within a healthy middle range for their age (between the 25th and 75th percentile on a standard growth chart), and who weigh at least 20 kg.
• Children whose fasting blood sugar and sugar tolerance test results fall within the normal range.
• Children who are not currently taking insulin or any diabetes medication.
• Children whose pancreas is still producing its own insulin, shown by a specific blood test result (C-peptide level of 1.0 ng/ml or above, with the level more than doubling after a stimulation test).
• Children who have not yet been diagnosed with Stage 2 or Stage 3 Type 1 diabetes, and who have no history of blood sugar problems or diabetes symptoms.
• Children whose long-term blood sugar marker (HbA1c) is below 5.7%.
• Children who test positive for two or more diabetes-related antibodies at low levels, or who can be re-tested to confirm two or more antibodies if one antibody is found at a high level (confirm with trial site for exact antibody thresholds).
• Children whose legal guardians are able to give signed consent for them to take part, and children aged 13 and over who can give their own consent as well (in line with local law).
• Children whose legal guardians are able to monitor blood sugar levels at least three times a day and correctly give insulin if needed.
• Children with suitable vein access for blood draws.

Who may not be able to join:

• Children or guardians who do not wish to take part or have not signed a consent form.
• Children who have or are suspected to have a type of diabetes other than Type 1.
• Children younger than 6 or older than 16.
• Children with an IgA deficiency or a diagnosed immune system condition (more than 7 infections per year may also be a concern — confirm with trial site).
• Children whose pancreas insulin production results fall below the required levels on testing.
• Children with fasting or post-test blood sugar levels above the normal thresholds.
• Children whose HbA1c result is 5.7% or above.
• Children whose weight or BMI falls outside the required healthy middle range for their age, or who weigh less than 20 kg.
• Children with a history of allergic reaction to anti-CD20 treatments or any components of the trial medication.
• Children with a history of allergic reaction to penicillin or streptomycin.
• Children with a past or current infection including hepatitis B or C, HIV, HTLV I/II, tuberculosis, or syphilis — a positive laboratory result is enough, even without symptoms.
• Children with an active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection, shown by a positive IgM result.
• Children with any current fungal, parasitic, viral, or bacterial infection.
• Children with a past or current cancer diagnosis.
• Children found within the last 6 weeks to have low red blood cells, low white blood cells, low infection-fighting cells, or low platelets for their age.
• Children with a history of blood clots or signs of increased clotting activity.
• Children currently taking any medication on an ongoing basis for more than 3 months for any condition.
• Children diagnosed with any autoimmune disease other than Type 1 diabetes, including a history of Hashimoto's thyroid disease or coeliac disease.
• Children who have taken any diabetes medication, including insulin, in the 4 weeks before joining the trial.
• Children with a history of eye disease affecting the retina (retinopathy).
• Children with a history of high blood pressure.
• Children with a current or past history of protein in the urine (albuminuria).
• Girls who are able to become pregnant and are either pregnant, or who are unwilling to use effective contraception throughout the trial and for up to 4 months after it ends.
• Children who are currently breastfeeding.
• Males over 15 years old who intend to father a child or donate sperm during the trial or within 4 months after it ends.
• Children or guardians who experience significant anxiety about the procedures involved in the trial.
• Children with any medical condition that, in the investigator's opinion, could put their health at risk if they take part.
• Guardians or children over 15 with a known alcohol or psychoactive substance addiction.
• Children with a history of any illness whose cause has never been identified.
• Children with a history of Creutzfeldt-Jakob disease.
• Children with a history of progressive memory loss, dementia, or degenerative neurological disease, including of unknown origin.
• Children who have previously been treated with hormones derived from the human pituitary gland, such as certain growth hormones.
• Children currently receiving immunosuppressant medication.
• Children who have had a corneal, scleral, or dural transplant, or neurosurgery that was not fully documented.
• Children with a history of travel to regions where exposure to local infectious diseases may have occurred.
• Children showing physical signs that suggest risk of an infectious disease.
• Children who have previously received a transplant from an animal source (xenogeneic transplant).

Important: Always verify eligibility with the trial site directly before applying.