EUCTR2019-003265-17-FIActive, not recruitingPhase 1
Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D) - MELD-ATG
niversitair Ziekenhuis Leuven (UZ Leuven)0 sites114 target enrollmentStarted: December 21, 2020Last updated:
Conditions
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. Individuals 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: 117
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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:
- •- Immunodeficient or clinically significant chronic leucopenia, neutropenia, lymphopenia or thrombocytopenia at the screening visit, according to local reference ranges
- •- Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limit of normal (ULN), at screening
- •- Evidence of renal dysfunction with creatinine greater than 1.5 times the ULN at screening
- •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, other than skin
- •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
- •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
Investigators
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