EUCTR2018-004179-11-ITActive, not recruitingPhase 1
Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagictelangiectasia and symptomatic gastrointestinal bleeding, SAIPAN-trial: a multicentre,randomized, open-label, parallel-group, superiority trial. - SAIPAN study
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 38
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •· Patients older than 18 years with written informed consent.
- •· Diagnosis of HHT: either confirmed by genetic testing or the Curaçao criteria
- •(definite diagnosis)
- •· 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.
- •· Substantial transfusion dependency: at least 4 blood units and / or intravenous
- •iron in the 6 months prior to study inclusion with:
- •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 Haemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions due to anaemia
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
- •· Liver cirrhosis Child-Pugh C,
- •· Insuloma,
- •· Uncontrolled diabetes mellitus as defined by HbA1c >64 mmol/ml, despite adequate
- •· Juvenile Polyposis Syndrome
- •· Symptomatic cholecystolithiasis (possible side-effect octreotide)
Investigators
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