EUCTR2014-004032-19-NL进行中（未招募）不适用
A randomised, open-label clinical trial assessing the efficacy of octreotide to decrease iron infusion and blood transfusion requirements in patients with refractory anaemia due to gastrointestinal bleeding from angiodysplasias. - OCEA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias without any other possible source of bleeding, who are blood transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.
- •1. Diagnosis of angiodysplasia is made by upper, lower gastrointestinal endoscopy and video capsule or enteroscopy. Single or multiple 2–5 mm flat bright red spots with round uniform or slightly irregular margins, or lesions appearing as raised and reddened areas with a distinctly irregular margin, when larger than 5 mm are seen.
- •2. Transfusion dependent: at least 2 blood transfusions or iron infusions in the 6 months before inclusion, despite an attempt to supplement iron orally.
- •3. Failure of endoscopic therapy: at least one attempt with single balloon enteroscopy or dubbel balloon enteroscopy to coagulate the angiodysplasias with APC within the year of diagnosis of symptomatic AD.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- age < 45 years
- •- liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
- •- previous unsuccessful treatment with octreotide for the same indication (refractory anaemia due to angiodysplasias)
- •- current thalidomide treatment which is effective (no blood transfusion dependency)
- •- patients with chronic renal failure who have a GFR < 30 ml/min
- •- severe diseases with life expectancy < 1 year
- •- patients with left ventricular assist devices (LVAD’s)
- •- Rendu-Osler-Weber
- •- pregnancy or nursing women
- •- uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy
- •- hereditary hemorrhagic diseases or haematological disorders with active treatment
- •- patients with a known hypersensitivity to SST analogues or any component of the sandostatin LAR formulations
- •- symptomatic cholecystolithiasis
- •- non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment
- •- systemic cancer currently undergoing chemotherapy or radiation therapy
- •- refusal to enter the study
- •- no understanding of Dutch or English
研究者
相似试验
进行中（未招募）
1 期
A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitisAutoimmune hepatitisEUCTR2016-001038-91-NLeiden university medical centre
进行中（未招募）
1 期
A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitisAutoimmune hepatitisEUCTR2016-001038-91-BEeiden university medical centre70
已完成
3 期
A randomised, controlled clinical trial assessing the efficacy of;Lanreotide to halt disease progression in ADPKDpolycystic kidney disease100383601001965410029149Autosomal Dominant Polycystic Kidney DiseaseNL-OMON39497niversitair Medisch Centrum Groningen300
进行中（未招募）
不适用
To investigate the effect of Lanreotide on renal function decline in ADPKD patientsFirst, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measuredby change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotidemodifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liverdisease as measured by change in liver volume.MedDRA version: 14.1Level: LLTClassification code 10023433Term: Kidney polycysticSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-005017-37-NLDIPAK Consortium
进行中（未招募）
不适用
A randomized, open-label clinical trial to identify predictive factors for controlled ovarian stimulation using a fixed daily dose of 200 IU of recombinant FSH in a GnRH antagonist regimen with or without oral contraceptive schedulingControlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) programEUCTR2006-000481-37-DEV Organon440