Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02215200 | ATG-GCSF in New Onset Type 1 Diabetes | PHASE2 | COMPLETED | 89 | — | — | Dec 1, 2014 | Aug 1, 2018 | Mar 2, 2020 | 13 | United States |
The C-peptide 2 hour area under the curve (AUC) mean is calculated at baseline and 12 months and measured in nmol/L. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis").
| Arm | Type | Description |
|---|---|---|
| Anti-Thymocyte Globulin (ATG) and Placebo | EXPERIMENTAL | Anti-Thymocyte Globulin (ATG)/Placebo: Anti-Thymocyte Globulin (ATG) will be administered at a dose of 2.5mg/kg as two divided IV infusions of 0.5mg/kg and 2mg/kg. First dose (0.5mg/kg) will be infused over a minimum of 12 hours, and the second dose (2mg/kg) over a minimum of 8 hours. The second dose should be given no less than 12 and no more than 24 hours after the previous dose. Placebo(for GCSF) treatment will begin 6 hours after completion of the ATG. Placebo will be given subcutaneously every 2 weeks for a total of 6 doses |
| ATG plus Granulocyte colony stimulating factor (GCSF) | EXPERIMENTAL | Granulocyte colony stimulating factor (GCSF) is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg GCSF (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection, U.S. Pharmacopeial Convention (USP). The standard 6mg dose will be given with the exception of subjects who weigh less than 45 kg. GCSF treatment will begin 6 hours after completion of the ATG / Placebo. GCSF will be given subcutaneously every 2 weeks for a total of 6 doses |
| Placebo | PLACEBO_COMPARATOR | Placebo for ATG will be administered by IV infusion in 2 doses. Placebo for GCSF will be administered subcutaneously every 2 weeks for a total of 6 doses |
| Name | Type | Description |
|---|---|---|
| Anti-Thymocyte Globulin (ATG) | DRUG | Thymoglobulin |
| Granulocyte colony stimulating factor (GCSF) | DRUG | Granulocyte colony stimulating factor (GCSF) |
| Placebo (for ATG) | DRUG | Normal saline administered by IV infusion to mimic ATG |
| Placebo (for GCSF) | DRUG | Placebo prepared to mimic 6mg subcutaneous injection of GCSF |
Inclusion Criteria: * Must be \> 12 years \< 46 * Must have a diagnosis of T1D for less than 100 days at randomization * Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is \<18 years of age * Positive for at least one islet cell autoant...