ATG-GCSF in New Onset Type 1 Diabetes
Trial ID or NCT#
NCT02215200
Status
RECRUITING
Purpose
This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D). The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.
Official Title
Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes
Eligibility Criteria
Ages Eligible for Study: 12 Years to 45 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 autoantibody; glutamic acid decarboxylase 65 (GAD65A), Insulin micro IAA (mIAA), if obtained within 10 days of the onset of insulin therapy, islet antigen 2 (IA-2A), Islet Cell Antigen (ICA), or zinc transporter 8 (ZnT8A) - Must have stimulated C-peptide levels = 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization - Must be Epstein-Barr virus (EBV PCR) negative within two weeks of randomization if EBV seronegative at screening - Be at least 6 weeks from last live immunization - Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available - Be willing to forgo vaccines during the treatment period and for 3 months following last dose of study drug - Be willing to comply with intensive diabetes management
Exclusion Criteria:
- - Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL). - Have active signs or symptoms of acute infection at the time of randomization - Have evidence of prior or current tuberculosis infection as assessed by purified protein derivative (PPD), interferon gamma release assay (IGRA) or by history - Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period - Require use of other immunosuppressive agents including chronic use of systemic steroids - Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection - Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, chronic obstructive pulmonary disease (COPD), sickle cell disease, neurological, or blood count abnormalities - Have a history of malignancies other than skin - Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal - Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal - Vaccination with a live virus within the last 6 weeks - Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening - Active participation in another T1D treatment study in the previous 30 days - Prior treatment with abatacept or anti-cd3 - Known allergy to GCSF or ATG - Prior treatment with ATG or known allergy to rabbit derived products - Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
View on ClinicalTrials.gov
