ISRCTN16067611已完成1 期
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
Cardiff University (UK)0 个研究点目标入组 6 人开始时间: 2016年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
2022 Results article in https://doi.org/10.1093/immadv/ltac002 (added 20/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
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EE-ASI 1MedDRA version: 18.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 1 diabetesEUCTR2015-003934-28-SECardiff University4
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EE-ASI 1Type 1 diabetesEUCTR2015-003934-28-GBCardiff University4
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Enhanced Epidermal Antigen Specific Immunotherapy Trial -1Type 1 DiabetesNCT02837094Cardiff University6
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