EUCTR2007-000189-19-BE进行中（未招募）不适用
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease
Italfarmaco S.p.A.0 个研究点目标入组 80 人开始时间: 2007年8月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •- Age: above 18 years
- •- Diagnosis of CD, re-established by endoscopy and/or X-ray and/or surgery in the last 36 months
- •- CD in active phase since at least 2 weeks before screening
- •- CDAI between 220 and 450
- •- CDEIS > 8
- •- Ulcerations greater than aphthous ulcers in at least 1 of the bowel segments from ileum to rectum
- •- If any on-going treatment with corticosteroids (prednisone,prednisolone or budesonide), it must be at a dose equivalent to or less than 30 mg/day prednisone, or 9 mg of budesonide, and in use for at least one month and at a stable dose for at least two weeks before patient enrolment
- •- If any on-going treatment with immunosuppressant (azathioprine, 6-mercaptopurine, methotrexate), it must be in use for at least 3 months before patient enrolment
- •- If any on-going treatment with 5-aminosalicilates, it must be in place for at least 4 weeks before patient enrolment, at a dose ? 2 g
- •- Females of childbearing potential with negative pregnancy tests
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Treatment in the 2 months with anti-TNF? antibodies and in the previous 3 months with cytokines inhibitors or experimental drugs
- •- Primary failure to previous treatment with anti-TNF? antibodies-
- •- Current bowel obstruction or any condition that may predispose to its development (e.g. clinically significant unresolved intestinal stricture, adhesions or any other condition that would place the patient at risk for developing overt bowel obstruction) or intestinal perforation or significant GI hemorrhage
- •- Expected surgery for the duration of the study
- •- Any ostomy or extensive bowel resection
- •- Positive serological anti-HCV and anti-HIV testing and positive testing for active HBV replication, e.g. HBV-DNA or HBsAg or HBeAg (to be performed at screening)
- •- Other on-going clinical relevant viral infections (e.g. herpes zoster, Epstein-Barr, CMV), systemic fungal infections or history of recurrent serious bacterial infections
- •- Signs and symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- •- Any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure
- •- QTc interval > 450 msec at pre-treatment evaluation
- •- Serum magnesium and potassium below the LLN at pre-treatment evaluation
- •- Platelet counts below 200 x 109/L at pre-treatment evaluation
- •- Any previous evidence, irrespective of its severity, of renal function impairment
- •- Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes
- •- Presence of a transplanted organ
- •- History of cancer with less than 5 years documentation of a disease-free state
- •- History of tuberculosis
- •- Severe lactose intolerance
- •- Pregnant or nursing women
- •- Female of childbearing potential without using a safe contraceptive measure
- •- Participation in a clinical trial within 30 days prior to initiation of study treatment
研究者
相似试验
进行中（未招募）
不适用
Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23Crohn's diseaseMedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's diseaseEUCTR2007-000189-19-ITITALFARMACO80
进行中（未招募）
1 期
Study to investigate the efficacy and safety of dronabinol in the improvement of chemotherapy-induced and tumor-related symptoms in patients with advanced pancreatic cancer during first-line chemotherapyEUCTR2019-000616-28-ATAGMT gGmbH104
进行中（未招募）
1 期
Assessment of efficacy of CR8020 and CR6261, monoclonal antibodies, against influenza infectioMedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsInfluenzaEUCTR2013-003341-41-BECrucell Holland B.V.296
进行中（未招募）
不适用
Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisrelapsing-remitting multiple scelorsisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2008-006786-92-HUActelion Pharmaceuticals Ltd400
进行中（未招募）
1 期
Multicenter, randomized, double-blind, placebo-controlled, Phase IIa study to evaluate the efficacy, safety, and tolerability of ACT-128800, an S1P1 receptor agonist, administered for 6 weeks to subjects with moderate to severe chronic plaque psoriasisEUCTR2008-001443-19-FRActelion Pharmaceuticals Ltd60