EUCTR2020-001926-71-DE进行中（未招募）1 期
A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual ß-cell function at baseline. - GLADIATOR
Dompe farmaceutici s.p.a.0 个研究点目标入组 327 人开始时间: 2020年9月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 327
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
- •Consented male and female patients aged 14-45 years, inclusive, with
- •recent onset T1D (randomization scheduled to allow the administration
- •of the study medication to start within 180 days from 1st insulin
- •administration). Patients must be positive for at least one diabetesrelated auto-antibody (anti-GAD; IAA, if obtained within 10 days of the
- •onset of insulin therapy; IA-2 antibody; ZnT8); must require, or have
- •required insulin delivered via one or more separate subcutaneous
- •injections or Continuous Subcutaneous Insulin Infusion (CSII); must
- •have a fasting C-peptide below 0.205 nmol/L, but must retain a Beta-cell
- •function as per peak stimulated (MMTT) C-peptide level >0.2 nmol/L.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 127
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients will be excluded if they have a type 2 diabetes or any other
- •unstable chronic disease for which dose adjustment of specific
- •medication is anticipated during the trial; moderate to severe renal
- •impairment calculated by estimated Glomerular Filtration Rate (eGFR)
- •<60 mL/min/1.73 m2 as determined using Chronic Kidney Disease
- •Epidemiology Collaboration (CKD-EPI) creatinine equation; hepatic
- •dysfunction (increased ALT/AST >3 x upper limit of normal and
- •increased total bilirubin >3 mg/dL [>51.3 µmol/L]); hypoalbuminemia (serum albumin <3 g/dL); a QTcF > 470 msec.; a history of significant
- •cardiovascular disease/abnormality; occurrence of an episode of
- •ketoacidosis or hypoglycemic coma in the past 2 weeks; a known
- •hypersensitivity to non-steroidal anti-inflammatory drugs. Patients on
- •treatment with drugs metabolized by CYP2C9 with a narrow therapeutic
- •index [i.e. phenytoin, warfarin, sulphanylurea hypoglycemics and high
- •dose of amitriptyline (>50 mg/day)]; patients with past (within 2 weeks
- •prior to randomization) or current use of antidiabetic agents as
- •metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
- •liraglutide, DPP-IV inhibitors, SGLT-2 inhibitors or amylin, or any
- •medications known to influence glucose tolerance (e.g. beta-blockers,
- •angiotensin-converting enzyme inhibitors, interferons, quinidine
- •antimalarial drugs, lithium, niacin, etc.) will also be excluded. Patients
- •will be excluded as well in case of past (within 1 month prior to
- •randomization) or current administration of any immunosuppressive
- •medications (including oral or systemic corticosteroids) and use of any
- •investigational agents, including any agents that impact the immune
- •response or the cytokine system. Additional exclusion criteria will be:
- •significant systemic infection during the 4 weeks before the 1st dose of
- •study drug (e.g., infection requiring hospitalization, major surgery, or
- •i.v. antibiotics to resolve; other infections, e.g. bronchitis, sinusitis,
- •localized 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); History of positive status
- •for hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C
- •and HIV. Also, pregnant or breastfeeding women or patients unwilling to
- •use effective contraceptive measures (females and males) will be
研究者
相似试验
进行中（未招募）
1 期
Study of the efficacy and safety of lenalidomide as maintenance therapy for high risk patients with chronic lymphocytic leukemia.EUCTR2011-004698-98-ESDeutsche CLL-Studiengruppe, Innere Medizin I, Uniklinik Köln89
进行中（未招募）
1 期
Reparixin in pancreatic islet transplantatioPancreatic islet transplantationMedDRA version: 17.0Level: PTClassification code 10058846Term: Pancreas islet cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-006201-10-CZDompé s.p.a.42
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of a combination of pro-netupitant/palonosetron intravenously administered for the prevention of chemotherapy-induced nausea and vomiting.nausea and vomiting in cancer patients receiving highly emetogenic therapyMedDRA version: 19.0Level: LLTClassification code 10036899Term: Prophylaxis against chemotherapy induced vomitingSystem Organ Class: 100000004865EUCTR2015-001800-74-CZHelsinn Healthcare SA400
进行中（未招募）
1 期
A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)Growth hormone deficiencyMedDRA version: 17.1Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disordersEUCTR2014-003796-32-DETeva Pharmaceutical Industries Ltd.150
进行中（未招募）
1 期
patients with blood cancer (chronic lymphocytic leukemia) receive daily lenalidomide tablets shortly after their first chemotherapy if they are in danger to have an early progess of the disease.Revlimid is indicated for maintenance therapy in high risk patients (age 18 or older) with CLL who have achieved partial or complete response following first line therapy and have eitherMRD levels in the peripheral blood at final restaging of >10-2 or =10-4 - <10-2 combined with an unmutated IgVH-status or 17p-deletion or TP53 mutationMedDRA version: 19.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004698-98-DEniversität zu Köln200