Clinical Research
Clinical Trials in Abdominal Transplantation
Clinical trials within the Divison of Abdominal Transplantation include: Tolerance Induction, EVB-induced post-transplant lymphoma, and the following Stanford-based trials for liver, kidney, intestine, pacreas, diabetes, and hepatocellular carcinoma.
This page provides an auto-populated up-to-date list of Stanford Clinical Trials in: liver, kidney, intestine, pancreas, diabetes, hepatocellular carcinoma, and pediatric transplant.
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Tocilizumab (TCZ)
- drug: Placebo
- other: Standard of Care
Eligibility
Inclusion Criteria:
1. Male or female aged 6-45 years*
-*Current Institutional Review Board (IRB)-approved age eligibility criteria is
restricted to subjects 6 to 17 years of age at time of study enrollment
2. Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association
T1DM criteria, within 100 days of study enrollment
3. Positive for at least one diabetes-related autoantibody, including but not limited to:
1. Glutamate decarboxylase (GAD-65)
2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
3. Insulinoma antigen-2 (IA-2)
4. Zinc transporter-8 (ZnT8)
4. Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test
(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
(V0)
5. Signed informed consent (and informed assent of minor, if applicable).
Exclusion Criteria:
1. Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
2. History of malignancy or serious uncontrolled cardiovascular, nervous system,
pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
3. Any history of recent serious bacterial, viral, fungal, or other opportunistic
infections
4. Have serologic evidence of current or past HIV (Human immunodeficiency virus),
Hepatitis B, or Hepatitis C
5. Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
6. Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000
copies per mL of whole blood
7. Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000
copies per mL of whole blood
8. Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine
aminotransferase (ALT), Aspartate aminotransferase (AST), or both > 1.5 x the upper
limit of age-determined normal (ULN) or total bilirubin > ULN
9. Current or prior treatment that is known to cause a significant, ongoing change in the
course of T1D or immunologic status
10. Current or prior (within last 30 days) use of drugs other than insulin to treat
hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
11. Current use of any medication known to significantly influence glucose tolerance
(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
12. Any of the following hematologic abnormalities, confirmed by repeat tests:
1. White blood count <3,000/microL or >14,000/microL
2. Lymphocyte count <500/microL
3. Platelet count <150,000 /microL
4. Hemoglobin <8.5 g/dL
5. . Neutrophil count <2,000 cells/microL.
13. Females who are pregnant, lactating, or planning on pregnancy during the 2- year study
period
14. History or diagnoses of other autoimmune diseases with the exception of stable thyroid
or celiac disease
15. History of alcohol, drug or chemical abuse within 1 year prior to study eligibility
screening evaluation
16. Any medical or psychological condition that in the opinion of the principal
investigator would interfere with safe completion of the trial
17. Prior participation in a clinical trial that could increase risks associated with this
clinical trial
18. Receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated
intranasal influenza vaccine, bacillus Calmette-Guérin, and small pox) in the 6 weeks
before randomization
19. High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
20. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450
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