EUCTR2010-019157-17-FR进行中（未招募）1 期
Evaluation of the safety and tolerability of re-dosing with intravenous (IV)otelixizumab in adult subjects with newlydiagnosed type 1 diabetes mellitus.
GlaxoSmithKline Research and Development LTD0 个研究点目标入组 0 人开始时间: 2010年7月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, aged 18 to 45 years, inclusive, at the time of anticipated first dose of
- •study drug.
- •2. A female subject is eligible to participate if she is of:
- •a. Non-childbearing potential defined as:
- •i. pre-menopausal females with a documented tubal ligation or
- •hysterectomy; or
- •ii. post-menopausal defined as 12 months of spontaneous
- •amenorrhoea [in questionable cases a blood sample with
- •simultaneous follicle stimulating hormone (FSH) > 40 mIU/ml and
- •estradiol <40pg/ml (<140 pmol/L) is confirmatory].
- •b. Child-bearing potential and agrees to use one of the contraception methods
- •listed below:
- •?? abstinence
- •?? oral contraceptive, either combined or progestogen alone
- •?? injectable progestogen
- •?? implants of levonorgestrel
- •?? oestrogenic vaginal ring
- •?? percutaneous contraceptive patches
- •?? intrauterine device (IUD) or intrauterine system (IUS) that has a
- •failure rate of <1% per year as stated in the product label
- •?? male partner sterilisation (vasectomy with documentation of
- •azoospermia) prior to the female subject’s entry into the study, and this
- •male is the sole partner for the subject
- •?? double barrier method: condom and an occlusive cap (diaphragm or
- •cervical/vault caps) with a vaginal spermicidal agent
- •(foam/gel/film/cream/suppository)
- •Adequate contraception must be used from the beginning of the screening period or
- •at least 14 days prior to dosing until at least 60 days after the last dose of the second
- •treatment course of study drug.
- •Male subjects with partners of childbearing potential must use a barrier method of
- •contraception from the day of the first dose of study drug until at least 60 days after
- •the last dose or they must have had a vasectomy. This applies to both dosing
- •3. a. Diagnosis of diabetes mellitus according to ADA and WHO criteria (see
- •Appendix 1), with an interval of = 90 days between the initial diagnosis and the first
- •dose of study drug. Documentation of the diagnosis of DM, including the date of
- •diagnosis, must be obtained from the diagnosing physician.
- •b. History and clinical course consistent with type 1a (autoimmune) DM.
- •Please refer to the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant, breastfeeding, or planning to become pregnant from the beginning of the screening period or at least 14 days prior to initial dosing until at least 60 days after the last dose of the second treatment course of study drug.
- •2. Current or prior malignancy, other than non-melanoma skin cancer (subject must
- •have had fewer than 5 occurrences of non-melanoma skin cancer, and the last
- •occurrence must not be within 3 months of study entry).
- •3. Clinically significant abnormal laboratory values during the Screening period, other
- •than those due to T1DM. Permitted ranges for selected laboratory values are shown
- •in Table 2. A clinically significant abnormal value will not result in exclusion if,
- •upon re-test, the abnormality is resolved or becomes clinically insignificant.
- •4. Significant and/or active disease in any body system likely to increase the risk to the subject or interfere with the subject’s participation in or completion of the study.
- •Examples of significant diseases include, but are not limited to, coronary artery
- •disease, congestive heart failure, uncontrolled hypertension, renal failure,
- •emphysema, history of bleeding peptic ulcers, history of seizure(s), addiction to
- •illicit drugs, and alcohol abuse.
- •5. Current or chronic history of liver disease, known hepatic or biliary abnormalities
- •(with the exception of Gilbert’s syndrome or asymptomatic gallstones), presence of
- •hepatitis B surface antigen (HBsAg), positive hepatitis C test result within 3 months
- •of screening
- •6. Significant systemic infection during the 6 weeks before the first dose of study drug
- •(e.g., infection requiring hospitalisation, major surgery, or IV antibiotics to resolve;
- •other infections, e.g., bronchitis, sinusitis, localised cellulitis, candidiasis, or urinary
- •tract infections, must be assessed on a case-by-case basis by the investigator
- •regarding whether they are serious enough to warrant exclusion).
- •7. History of current or past active tuberculosis infection and or latent tuberculosis
- •infection (as per Centers for Disease Control [CDC] Guidelines) [Center for Disease
- •Control and Prevention, 1995]. This eligibility criterion can be met with a negative
- •purified protein derivative (PPD) test result during Screening or a documented
- •negative result within 6 months prior to dosing. In specific circumstances (e.g., the
- •subject has a history of BCG [Bacille Calmette-Guérin] vaccination, a positive
- •Screening PPD test that is believed to be a false positive result, or the investigator
- •does not believe it is safe to perform a Screening PPD test), this criterion may be met
- •by other means following a diagnostic algorithm determined in consultation with the
- •medical monitor. This diagnostic algorithm will include:
- •a) A complete clinical evaluation, including, at a minimum, BCG vaccination
- •history, tuberculosis exposure history, and clinical signs and symptoms suggestive
- •of tuberculosis infection; and
- •b) In consultation with the medical monitor, further testing to rule out a false
- •positive Screening PPD test or to rule out latent tuberculosis in place of a
- •Screening PPD test may include IFN? testing (e.g., QuantiFERON-TB assay)
- •and/or chest X-ray.
- •8. A positive test for human immunodeficiency virus (HIV) antibody or risk factors
- •which predispose subject to HIV infection.
- •9. EBV viral load of =10,000 copies per 106 peripheral blood mononuclear cells
- •(PBMCs) as determined by quantitative polymerase chain reaction (qPCR). If there
- •is any clinical suspicion that a subj
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