EUCTR2019-003265-17-DKActive, not recruitingPhase 1
Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D)
niversitair Ziekenhuis Leuven, Belgium0 sites114 target enrollmentStarted: January 7, 2022Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 114
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Has given written informed consent to participate; or have a parent or legal guardian provide written informed consent. Individual under the age of consent will be asked to assent to trial participation.
- •2. Be aged =5 years to =25 years at written informed consent/assent
- •3. Have been diagnosed with T1D within 3–9 weeks of planned treatment day 1
- •4. Have random C-peptide levels =200 pmol/L measured at screening, as tested centrally
- •5. Have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
- •6. Will be =6 weeks from last live immunisation at planned treatment day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment
- •7. Be willing to comply with intensive diabetes management
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 114
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Exclusion criteria
- •1. Type 2 diabetes
- •2. Evidence of prior or current tuberculosis (TB) infection
- •3. Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including:
- •o Immunodeficient or clinically significant chronic leucopenia, neutropenia, lymphopenia or thrombocytopenia at the screening visit, according to local reference ranges
- •o Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limit of normal (ULN), at screening
- •o Evidence of renal dysfunction with creatinine greater than 1.5 times the ULN at screening, adjusted for the age of the patient
- •o Clinically significant clotting disorder, according to local reference ranges
- •4. Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
- •5. Any active chronic infections at screening, or any active acute or chronic infections at baseline or on treatment day, which would contraindicate any additional immunosuppression
- •6. Seropositive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection at screening
- •7. Positive for SARS-CoV-2 based on local testing regimen
- •8. Unwilling to use appropriate contraception if sexually active during the trial, from date of written informed consent until completion of the 12-month follow up visit
- •9. Any history of malignancies
- •10. Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control
- •11. Active participation in another T1D treatment interventional trial in the previous 30 days prior to screening (excluding treatment with insulin)
- •12. Any prior treatment with ATG, Abatacept or anti-CD3
- •13. Known allergy to ATG or to similar products, or hypersensitivity to rabbit proteins or to any of the excipients
- •14. Any condition, complicating medical issues, or abnormal clinical laboratory results that the investigator judges may adversely affect trial conduct, cause increased risk to the participant, or compromise the trial results
- •15. Pregnant and breastfeeding women
- •16. allergy for rabbit protein
Investigators
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