Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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22 August 2022 |
Main ID: |
ISRCTN16067611 |
Date of registration:
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06/09/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Enhanced epidermal antigen specific immunotherapy trial - Type 1 Diabetes
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Scientific title:
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Enhanced Epidermal Antigen Specific Immunotherapy trial -1 (EE-ASI-1): a Phase 1a study of gold nanoparticles administered intradermally by microneedles to deliver immunotherapy with a proinsulin derived peptide in Type 1 diabetes |
Date of first enrolment:
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01/08/2016 |
Target sample size:
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8 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN16067611 |
Study type:
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Interventional |
Study design:
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Non-randomised study (Prevention)
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Phase:
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Phase I
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Countries of recruitment
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Sweden
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United Kingdom
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Wales
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Contacts
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Name:
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Rachel
Stenson |
Address:
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T1D UK Immunotherapy Research Consortium Manager
Room 2TB2 165B, C2 Link
I&I, School of Medicine
Cardiff University
Heath Park
CF14 4XW
Cardiff
United Kingdom |
Telephone:
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+44 (0)29 20742182 |
Email:
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StensonR@cardiff.ac.uk |
Affiliation:
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Name:
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Colin
Dayan |
Address:
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Cardiff University
School of Medicine
Heath Park
CF14 4XW
Cardiff
United Kingdom |
Telephone:
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+44 (0)29 20742182 |
Email:
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DayanCM@cardiff.ac.uk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Clinical diagnosis of type 1 diabetes for > 3 months (dated from the first insulin injection) 2. Commenced on insulin treatment within 1 month of diagnosis 3. Age 16 to 40 years 4. 2 hour post-meal UCPCR > 0.53 nmol/mmol on at least one occasion (maximum 3 tests on different days) 5. Possession of 0401 allele at the HLA-DRB1 gene locus 6. The following birth control methods should be used (considered highly effective with a failure rate of less than 1% per year when used consistently and correctly): 6.1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: 6.1.1. Oral 6.1.2. Intravaginal 6.1.3. Transdermal 6.2. Progestogen-only hormonal contraception associated with inhibition of ovulation: 6.2.1. Oral 6.2.2. Injectable 6.2.3. Implantable 6.3. Intrauterine device (IUD) 6.4. Intrauterine hormone-releasing system ( IUS) 6.5. Bilateral tubal occlusion 6.6. Vasectomised partner (provided that the partner is the sole sexual partner of the trial participant and that medical assessment of azoospermia has been confirmed) 6.7. Sexual abstinence (defined as refraining from heterosexual intercourse during the duration of the trial) 7. Written and witnessed informed consent to participate
Exclusion criteria: 1. HbA1c > 86mmol/L (10%) 2. Females who are pregnant, breastfeeding or not using adequate forms of contraception 3. Previous diagnosis of renal disease including glomerulonephritis or nephropathy 4. Raised serum creatinine or abnormal urine albumin/creatinine ratio (ACR) (values above the laboratory reference range). If the initial ACR is raised, this should be repeated on two further occasions as first morning samples. The subject can be included if both of these samples are negative (within the reference range) 5. Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to receiving the IMP and any monoclonal antibody therapy given for any indication. Note that previous exposure to proinsulin peptide C19-A3 in a clinical trial is an exclusion criterion 6. Use of cannabis within one month prior to trial entry 7. Use of any hypoglycaemia agents other than insulin, for more than 6 weeks, at any time prior to trial entry 8. Use of inhaled insulin 9. Known alcohol abuse, drug abuse, HIV or hepatitis 10. Allergies to drug components or any excipients 11. Any other medical condition which, in the opinion of investigators, could affect the safety of the subject’s participation or outcomes of the study, including immunocompromised states and autoimmune conditions 12. Subjects should not have had immunisations (flu and others) for 1 month prior to trial entry and should not receive any during their time in the trial – see section 5.6 13. Recent subject’s involvement in other research studies which, in the opinion of investigators, may adversely affect the safety of the subjects or the results of the study 14. Abnormal ECG findings
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
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Intervention(s)
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IMP: C19-A3 GNP (gold nanoparticles) injected by Nanopass microneedles
Participants will have a blood test to assess whether they have the right tissue type for the study. If suitable, they will be asked to attend their local research centre for a general examination and further blood and urine tests. If the participant still has some insulin response after the post meal urine test they will proceed to the first injection. Each participant will have three injections of the same treatment, these are given 4 weeks apart. During the treatment, participants will undergo various monitoring including blood and urine tests, mixed meal tolerance tests, lymph node biopsies. A follow-up appointment will take place 6 weeks after the last injection.
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Primary Outcome(s)
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The safety (adverse event) profile of the investigational agent. The following time points are set for evaluation of adverse event profiles, but pharmacovigilance data will be collected at times points in between if events arise: 2 hours, 4 weeks, 8 weeks and 14 weeks
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Secondary Outcome(s)
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1. T cell responses to GNP C19A3 as determined by changes from baseline of interferon gamma and IL10 ELISPOT responses to this peptide in blood following treatment at weeks 0, 8 and 14 2. T cell responses to GNP C19A3 as determined by changes from baseline of interferon gamma and IL10 ELISPOT responses to this peptide in draining axillary lymph node before and after the first and last treatment administration 3. Changes in additional immunological biomarkers (e.g. flow cytometry profiles, T reg assays, beta cell and T-cell cell-free DNA markers) from baseline at week 0, 8 and 14 4. Effects on residual cpeptide secretion at week 12 as compared to baseline as assessed by a mixed meal tolerance test and a stimulated urine cpeptide test 5. Effects on glycaemic control assessed by blood sugar profiles and HbA1c at week 14 as compared to baseline 6. Questionnaires on quality of life and diabetes self-management at baseline and week 14
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Secondary ID(s)
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SPON1455-15
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2015-003934-28
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NCT02837094
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Source(s) of Monetary Support
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Seventh Framework Programme
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Ethics review
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Status:
Approval date:
Contact:
London - City & East Research Ethics Committee, 04/03/2016, ref: 16/LO/0020
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Results
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Results available:
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Date Posted:
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Date Completed:
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31/12/2019 |
URL:
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