EUCTR2018-004179-11-DE进行中（未招募）1 期
Effectiveness of Somatostatin Analogues in Patients with hereditaryhemorrhagic telangiectasia and symptomatic gastrointestinal bleeding,the SAIPAN-trial: a multicenter, randomized, open-label, parallel-group,superiority trial. - SAIPAN-trial
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
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Patients older than 18 years with written informed consent.
- •Diagnosis of HHT: either confirmed by genetic testing or the Curaçao criteria (definite diagnosis) (7).
- •Presence of 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, or other endoscopic treatment modality performed in the past 5 years.
- •Diagnosis of iron deficiency anemia (IDA). IDA is defined as:
- •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 and
- •o The absence of other common causes of anemia (Vitamin B12 and/or folate deficiency in patients with macrocytic anemia and bone marrow disorders in patients with pancytopenia)
- •Substantial transfusion dependency: at least 4 blood units and / or intravenous iron in the 6 months prior to study inclusion.
- •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
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Liver cirrhosis Child-Pugh C,
- •Insulinoma,
- •Uncontrolled diabetes mellitus as defined by HbA1c >64 mmol/ml, despite adequate therapy,
- •Juvenile Polyposis Syndrome
- •Symptomatic cholecystolithiasis (possible side-effect octreotide)
- •Chronic or acute pancreatitis
- •Bradycardia (heart rate below 50)*
- •Hypersensitivity to the active ingredient (octreotide) or to auxiliary materials of the study medication
- •Severe disease/comorbidities with a life expectancy < 1 year
- •Use of chemotherapy and / or ciclosporin
- •Pregnancy or nursing women or women who have a pregnancy wish during the study period.
- •Women of childbearing potential who do not have a confirmed menstrual period and a negative, highly sensitive urine or serum pregnancy test < 7 days before inclusion
- •Women of childbearing potential who do not use a highly effective contraceptive measure (according to section 4.1 of the Recommendations related to contraception and pregnancy testing in clinical trials of the Heads of Medicines Agencies (HMA)) or refuse to maintain this measure during the entire treatment-and relevant systemic exposure period.(25)
- •Women of childbearing potential who refuse to undergo additional pregnancy testing during the treatment period
- •Use of other anti-angiogenic drug treatment (thalidomide and/or bevacizumab
- •Use of hormonal (estrogen) therapy and/or antifibrinolytic therapy (tranexamic acid) to treat anemia due to telangiectasia with sufficient effect. However, when patients are red blood cell transfusion or iron infusion dependent despite these treatment options and are naïve to octreotide treatment, patients are still eligible for inclusion.
- •*If a patient has a heart rate below 60 and uses cardiovascular medication that affect the heart rate (e.g. beta blockers and calcium channel blockers) the prescribing specialist (or another competent specialist) will be consulted about the possibility to adjust the dose of these medicines. Patients with a heartrate below 50 (despite dose adjustments) will be excluded from participation.
研究者
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