Onderzoek naar de effectiviteit van octreotide in hereditary hemorrhagic telangiectasia patiënten metdaarbij gastrointestinale bloedingen.

Not yet recruiting

• Conditions: Somatostatin analogues, somatostatine analoga, SSA, Octreotide, Thalidomide, Bevacizimab, transfusion requirement, transfusiebehoefte, hereditary hemorrhagic telangiectasia, Hereditaire hemorragische teleangië ctasieë n, HHT, Rendu-Osler-Weber, ROW, gastrointestinal bleeding, gastrointestinale bloeding, GI-bleeding.

• Registration Number: NL-OMON25382
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 38

Inclusion Criteria

Patients older than 18 years with written informed consent.

- Diagnosis of HHT: either confirmed by genetic testing or the Curacao criteria (definite diagnosis).

Exclusion Criteria

- liver cirrhosis child-pugh C.

- symptomatic cholecystolithiasis (possible side-effect octreotide).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
¡®Successful response¡¯, defined as a decrease of ¡Ý50% in the amount of units intravenous iron and/or blood transfusions given between the number of transfusions at baseline (26 weeks prior to study inclusion) and during the treatment study period (26 weeks).

Secondary Outcome Measures

Name	Time	Method
the percentual or mean/median difference between the half year prior to inclusion and the treatment period of a half year between the treatment and observational arm in:<br /><br /><br><br>- blood and intravenous iron requirements<br /><br>- PROM&acute;s: quality of life (SF-36, EQ-5D), level of fatigue (multidimensional fatigue inventory (MFI)-20), epistaxis severity (ESS tool), and patient satisfaction<br /><br>- hemoglobin and ferritin levels<br /><br>- number of endoscopic treatments<br /><br>- cost-effectiveness<br /><br>- Safety: All adverse events occurring during the study will be recorded in the patient's medical records.