EUCTR2007-003815-30-PT进行中（未招募）不适用
An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis
GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)0 个研究点开始时间: 2009年3月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •- 18-75 years old
- •- Active ulcerative colit is with documented clinical symptoms and endoscopic findings
- •- Active disease defined as DAI (Mayo score) = 4 and = 10 with at least 1 point in flexible sigmoidoscopy
- •- Steroid dependency as defined by: A. Inability to withdraw corticosteroids within three months of starting treatment, without recurrent active disease; B. Appearance of relapse within 3 months after withdrawal of corticosteroids
- •- Colonic involvement with ulcerative colitis beyond 15cm of the anal verge
- •- Stable doses: A. Aminosalicylates for the last 4 weeks; B. Prednisolone or equivalent dose = 20 mg/day for the last 2 weeks; C. Azathioprine or 6-mercaptopurine at stable dose for the last 12 weeks
- •- Signed informed consent form
- •- Agree to participate in the required follow-up visits
- •- Able to complete the diary
- •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
- •- Febrile (= 38ºC)
- •- Evidence of toxic megacolon
- •- Anticipated need for surgery within 24 weeks
- •- Known obstructive diseases of the gastrointestinal system
- •- Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
- •- A history of allergic reaction to heparin or heparin-induced thrombocytopenia
- •- A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
- •- Requires a central venous access catheter for the apheresis treatments
- •- Known infection with enteric pathogens, pathogenic ova or parasites, C. difficile toxin or CMV
- •- Hypotension (systolic blood pressure < 80 mmHg and/or diastolic blood pressure < 50 mmHg) at screening visit only
- •- Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg) despite medical therapy
- •- A history of myocardial infarction or unstable angina within the past 6 months
- •- A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
- •- Prosthetic heart valve, pacemaker or other permanent implant
- •- Severe cardiovascular or peripheral vascular disease, severe renal disease
- •- Liver disease defined as levels of SGOT [AST], SGTP [ALT] or alkaline phosphatase > 2.5x the upper limit of the normal range for the laboratory performing test
- •- History of cirrhosis
- •- Known bleeding disorder (PT or PTT > 1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
- •- Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
- •- Known infection with Hepatitis B or C, or HIV
- •- Abnormal hematology parameters defined as severe anemia with hemoglobin < 8.5g/dL, white blood cell count of < 3,500/µl and a granulocyte count < 2,000/µl
- •- Fibrinogen level > 700 mg/dl
- •- Major surgery within the past 6 months
- •- Infection: Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infection; Febrile viral infection within 4 weeks of entry into the clinical investigation; Less than 12 weeks from conclusion of therapy for systemic fungal infections
- •- Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
- •- History of dysplasia or carcinoma of the colon or lack of a complet colonoscopy in the last 12 months in patients with longstanding UC (> 10 years)
- •- Current drug or alcohol abuse
- •- Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
- •- Used within the last 30 days an investigational drug, biologic or device or 5 half-lifes, if known, for any investigational drug or biologic
- •- Received cyclosporine or tacrolimus within the last 8 weeks
- •- Received either infliximab or adalimumab within the last 8 weeks
- •- Received beclomethasone diproprionato (Clipper), oral budesonide, topical rectal steroids or 5-ASA within the last 2 weeks
- •- Fulminant ulcerative colitis
研究者
相似试验
进行中（未招募）
1 期
An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)EUCTR2008-002668-32-CZOasmia Pharmaceutical AB650
进行中（未招募）
不适用
A Clinical Study to Compare Efficacy and Safety of Two Formulations ofPaclitaxel in Patients with Recurrent Epithelial Ovarian Cancer, PrimaryPeritoneal Cancer or Fallopian Tube Cancer.Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.MedDRA version: 15.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-002668-32-LTOasmia Pharmaceutical AB850
进行中（未招募）
不适用
An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.MedDRA version: 9.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrentMedDRA version: 9.1Level: LLTClassification code 10052171Term: Peritoneal carcinomaMedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancerEUCTR2008-002668-32-FIOasmia Pharmaceutical AB650
进行中（未招募）
不适用
Study of Paclitaxel in Patients With Ovarian CancerEUCTR2008-002668-32-SEOasmia Pharmaceutical AB850
进行中（未招募）
不适用
An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)EUCTR2008-002668-32-LVOasmia Pharmaceutical AB650