An Open-label, Randomised, Multi-centre, Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Evaluate whether the intervention of TLA Gut™ reduces Human Leukocyte Antigen DR isotype (HLADRhi)
研究概览
简要总结
An open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of TLA Gut™ leukapheresis treatment in patients with UC. The aim of this trial is to evaluate the efficacy and safety of two different TLA Gut™ dose regimens in patients with acute exacerbation of UC. Enrolled patients will participate in a 6-week treatment phase and a 20- week follow-up phase. The treatment phase consists of two periods; 2 weeks in which patients will undergo two treatment sessions per week, followed by 4 weeks of a single treatment session per week. The follow-up phase consists of 2 visits, one visit at week 7 and the last visit at week 26. Telephone visits will be conducted between these visits. In all a patient will undergo 8 treatment visits and 2 follow-up visits. Only patients not having experienced an earlier recurrence will participate in the follow-up phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients 18 to 80 years of age
- •Active UC without Ileorectal anastomosis (IRA)
- •Active UC is defined as:
- •Total Mayo score of ≥ 6 to 11 points
- •Flexible rectosigmoidoscopy findings of 2 or 3 (0 inactive disease, 1; mild disease, 2; moderate disease or 3; severe disease)
- •Minimum extension of inflammation 10 cm from anus.
- •Active disease with no medical treatment OR Active disease despite receiving concomitant therapy with one or more of the following agents:
- •≤20 mg prednisolone daily. Stable dose ≥1 week prior to the start of the investigation.
- •5-Aminosalicylate (5-ASA) agents for ≥4 weeks and stable dose for ≥2 weeks (local or systemic administration)
- •Rectal administration of corticosteroids in a stable dose for ≥2 weeks
- •Azathioprine or 6-mercaptopurine for ≥8 weeks or stable dose ≥2 weeks
- •No anti-tumour necrosis factor (TNF) treatment (Adalimumab, Infliximab, Golimumab, Certolizumab), anti-integrin-treatment (vedolizumab), Interleukin (IL)-12/23 inhibitor (Ustekinumab) or Janus Kinase (JAK) treatment (Tofacitinib) during the last 4 weeks prior to entering the study
- •Patients with peripheral veins suitable for extracorporeal treatment - must be examined by the treating apheresis specialist
- •Willing and able to give written informed consent
排除标准
- •Involvement in any investigational drug or device trial within 30 days prior to this investigation
- •Patients with peripheral veins not suitable for extracorporeal treatment
- •Fever, defined as a temperature of >38,5 Celsius degrees (ºC), at the Screening Visit
- •Heart failure
- •Coronary artery disease
- •Cardiomyopathy
- •Valvular heart disease
- •Cardiac arrythmia class IV
- •Underweight person (BMI < 19)
- •Hypotension (< 90/55 mmHG)
- •Hypoproteinemia
- •Evidence of toxic megacolon
- •History of hypersensitivity to heparin
- •Heparin-induced thrombocytopenia
- •History of cerebrovascular incident
- •Known clinically significant bleeding disorder
- •Colectomy planned within 6 months
- •Concomitant anticoagulant therapy
- •History of hypercoagulable disorders
- •Severe anaemia or Leukopenia
- •Patients with active viral hepatitis and/or human immunodeficiency virus (HIV) infections
- •A positive urine pregnancy test at the screening visit
- •Patients that are nursing Local intestinal treatments with suppositories, enemas, creams, ointments or foams during the last 2 weeks
- •Current daily smoking habits
- •Patients unwilling to meet the requirements of the clinical investigational plan
- •Other medical or social reasons for exclusion at the discretion of the investigator
结局指标
主要结局
Evaluate whether the intervention of TLA Gut™ reduces Human Leukocyte Antigen DR isotype (HLADRhi)
时间窗: baseline, during treatment (after 4 treatment sessions at week 2)
Mean percentage change in HLA-DRhi expressing monocytes
次要结局
- Evaluate the effect of intervention of TLA Gut™ on clinical, histopathology and laboratory criteria and variables(immediately after treatment completion)
- Evaluate the effect of intervention of TLA Gut™ on laboratory criteria(baseline, during treatment (at week 6), immediately after treatment completion)
- Evaluate the effect of intervention of TLA Gut™ on clinical variables(baseline, after 4 treatment sessions at week 2 , immediately after treatment completion)