| Trial ID: | L5919 |
| Source ID: | NCT04509791
|
| Associated Drug: |
Anti-Human Thymocyte Immunoglobulin, Rabbit
|
| Title: |
MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)
|
| Acronym: |
Meld-ATG
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Anti-Human Thymocyte Immunoglobulin, Rabbit
|
| Outcome Measures: |
Primary: the area under the stimulated C-peptide response curve, over the first 2 hours of a mixed meal tolerance test (MMTT) at 12 months post treatment | Secondary: the area under the stimulated C-peptide response curve, over the first 2 hours of a MMTT at baseline, 3, 6 and 12 months|dry blood spot (DBS) C-peptide measurements, at all observation times|Cluster of differentiation 4 (CD4) positive T cells and Cluster of differentiation 8 (CD8) positive T cells, over 12 months|HbA1c, over 12 months|insulin requirements, The need for insulin (units) on a daily basis, over 12 months|T1D-associated autoantibodies (glutamic acid decarboxylase antibodies (GADA), insulin auto-antibodies (IAA), IA-2 antibodies (IA-2A) and Zinc transporter 8 antibodies (ZnT8A)), The presence of T1D-associated autoantibodies, over 12 months|continuous glucose monitoring (CGM) measurements ( time in range, time above time below), over 12 months
|
| Sponsor/Collaborators: |
Sponsor: Universitaire Ziekenhuizen KU Leuven
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
114
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-11-24
|
| Completion Date: |
2024-12-16
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-10
|
| Locations: |
Medical University of Graz, Graz, Austria|Medical University of Vienna, Vienna, Austria|Universitair Ziekenhuis Antwerpen, Antwerp, Belgium|Universitair ziekenhuis Brussel, Brussels, Belgium|Universite Libre de Bruxelles, Brussels, Belgium|Universitaire Ziekenhuizen Leuven, Leuven, Belgium|Herlev University Hospital, Herlev, Denmark|Helsinki University Hospital Children and Adolescents, Helsinki, Finland|Hannoversche Kinderheilanstalt Auf der Bult, Hannöver, Germany|IRCCS Ospedale San Raffaele, Milano, Italy|University Medical Centre Ljubljana, Ljubljana, Slovenia|Oxford University Hospitals NHS Foundation Trust, Oxford, Oxon, OX3 9DU, United Kingdom|Cambridge University Hospitals NHS Trust, Cambridge, United Kingdom|The Royal London Hospital - Barts Health NHS Trust, London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT04509791
|
