Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
NCT ID: NCT03179423
Last Updated: 2020-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2017-06-14
2019-05-07
Brief Summary
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This study is a multicentre study evaluating for the first time the safety and efficacy of GNbAC1 in T1D subjects for a first bouble-blind period of 20 weeks followed by an optional open-label period of 24 weeks. The primary objective of the study is to assess the safety and tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D. Secondary objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of T1D.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GNbAC1
Monthly IV repeated dose
GNbAC1
Monthly IV repeated dose
Placebo
Monthly IV repeated dose
Placebo
Monthly IV repeated dose
Interventions
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GNbAC1
Monthly IV repeated dose
Placebo
Monthly IV repeated dose
Eligibility Criteria
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Inclusion Criteria
* Peak stimulated C-peptide of ≥0.2 nmol/L during a mixed meal tolerance test performed during the Screening period;
* 18 to 55 years of age (both inclusive);
* Body weight \>40 to ≤100 kg;
* Subjects positive for at least one diabetes-associated autoantibody (insulin, glutaminic-acid-decarboxylase-65 \[GAD-65\], tyrosine phosphatase-related antigen 2 \[IA-2\], ZnT8 or islet-cell antibody \[ICA\]).
Exclusion Criteria
* Pregnant and nursing women.
18 Years
55 Years
ALL
No
Sponsors
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Southern Star Research
INDUSTRY
GeNeuro Australia PTY Ltd
INDUSTRY
Responsible Party
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Locations
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Macquarie University Hospital
Macquarie University, New South Wales, Australia
AIM Centre
Merewether, New South Wales, Australia
Northern Sydney Local Health District - Royal North Shore Hospital
St Leonards, New South Wales, Australia
Ipswich Research Centre
Ipswich, Queensland, Australia
Mater Misericordiae Ltd and Mater Medical Research Institute Limited
South Brisbane, Queensland, Australia
Gold Coast Hospital and Health Service
Southport, Queensland, Australia
Southern Adelaide Local Health Network - Repatriation General Hospital
Adelaide, South Australia, Australia
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Eastern Health
Box Hill, Victoria, Australia
St Vincent's Hospital (Melbourne) Limited
Fitzroy, Victoria, Australia
Barwon Health - University of Geelong
Geelong, Victoria, Australia
Heidelberg Repatriation Hospital
Heidelberg, Victoria, Australia
Keogh Institute of Medical Research
Nedlands, Western Australia, Australia
Countries
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Other Identifiers
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GNC-301
Identifier Type: -
Identifier Source: org_study_id
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