Status:
COMPLETED
MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
5-25 years
Phase:
PHASE2
Brief Summary
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient ...
Detailed Description
A phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial. Randomisation wil be stratified by age. The trial consist of seven cohorts. The first cohort o...
Eligibility Criteria
Inclusion
- 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
- be aged \> 5 years to \< 25 years at written informed consent/assent
- have been diagnosed with T1d within 3-9 weeks of planned treatment day 1
- have random C-peptide levels \> 200 pmol/L measured at screening, as tested centrally
- have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
- will be \> 6 weeks form last live immunisation at planned treatment day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment
- be willing to comply with intensive diabetes management
Exclusion
- Type 2 diabetes
- Evidence of prior or current tuberculosis (TB) infection
- Clinically significant abnormal full blood count (FBC), renal function or liver function at screening
- Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
- 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
- seropositive for human immunodeficiency virus (HIV),hepatitis B of hepatitis C infection at screening
- positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) based on local testing regimen
- 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
- any history of malignancies, other than skin
- current or ongoing use of non-insulin pharmaceuticals that effect glycaemic control
- active participation in another T1D treatment interventional trial in the previous 30 days prior to screening ( excluding treatment with insulin)
- any prior treatment with ATG, Abatacept or Anti-CD3 monoclonal antibody (Anti-CD3)
- known allergy to ATG or to similar products
- 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
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04509791
Start Date
November 24 2020
End Date
December 16 2024
Last Update
January 10 2025
Active Locations (14)
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1
Medical University of Graz
Graz, Austria
2
Medical University of Vienna
Vienna, Austria
3
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
4
Universitair ziekenhuis Brussel
Brussels, Belgium