Effectiveness of somatostatin analogues for GI bleeding in patients with hereditaryhemorrhagic telangiectasia

Phase 1

• Conditions: Hereditary hemorrhagic telangiectasia (HHT), also known as Osler–Weber–Rendu disease(in specific patients with gastrointestinal bleeding and transfusion dependency); MedDRA version: 21.0Level: PTClassification code 10019883Term: Hereditary haemorrhagic telangiectasiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2018-004179-11-IT
• Lead Sponsor: RADBOUD UNIVERSITY MEDICAL CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

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
therapy
· Juvenile Polyposis Syndrome
· Symptomatic cholecystolithiasis (possible side-effect octreotide)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified