EUCTR2018-004179-11-NL进行中（未招募）1 期
Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial. - SAIPAN-trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 38
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
入选标准
- •- Patients older than 18 years with written informed consent.
- •- Diagnosis of HHT: either confirmed by genetic testing or the Curacao criteria (definite
- •diagnosis).
- •- Presence of IDA in combination with the presence endoscopic proven GI AVM manifestations /
- •telangiectasias confirmed within the last 12 months (upper and/or lower endoscopy and/or
- •capsule endoscopy).
- •- Endoscopic refractory: at least 1 endoscopic APC / laser /other endoscopic treatment modality
- •performed in the past 5 years.
- •- Substantial transfusion dependency: at least 4 blood units and / or intravenous iron in the 6
- •months prior to study inclusion with a:
- •o At least one serum ferritin below < 30 ug/l within the last 6 months requiring iron
- •infusion above or equal to 1 g and/or
- •o Hemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions due to anemia related symptoms within the last 6 months requiring blood transfusion above.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •- liver cirrhosis child-pugh C.
- •- symptomatic cholecystolithiasis (possible side-effect octreotide).
- •- pregnancy or nursing women or women have a pregnancy wish during the study period.
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