Octreotide in Patients With GI Bleeding Due to Rendu-Osler-Weber

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02874326
• Date of registration: 17/08/2016
• Prospective Registration: Yes
• Primary sponsor: Radboud University
• Public title: Octreotide in Patients With GI Bleeding Due to Rendu-Osler-Weber ROW
• Scientific title: An Uncontrolled, Pilot-study Assessing the Efficacy of Octreotide Long-acting Release to Decrease Transfusion Requirements and Endoscopy Frequency in Patients With Rendu-Osler-Weber and Gastrointestinal Bleeding
• Date of first enrolment: October 2016
• Target sample size: 15
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02874326
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Joost Drenth, MD PhD
• Affiliation: Radboud University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with Rendu-Osler-Weber

- Symptomatic gastrointestinal bleeds out of telangiectasias

- Transfusion and / or endoscopy dependent:

Transfusion: at least 2 blood and/or iron infusions in the 6 months before inclusion.

Endoscopy: at least one endoscopy with APC after the initial endoscopic treatment after
diagnosis in the half year before inclusion or unsuitable for endoscopic therapy.

Exclusion Criteria:

- liver cirrhosis Child-Pugh C or acute liver failure

- previous unsuccessful treatment with somatostatin analogues (SST) for the same
indication (refractory anaemia due to telangiectasias) or current effective treatment
with a somatostatin analogue

- severe diseases with life expectancy < 1 year

- patients with left ventricular assist devices (LVAD's)

- Symptomatic cholecystolithiasis (without cholecystectomy)

- pregnancy or nursing women or women who have a pregnancy wish in the study period or
who use anticonception inadequate

- current chemotherapy

- patients with a known hypersensitivity to SST analogues or any component of the
octreotide LAR formulations

- no understanding of Dutch or English



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Hemorrhage

Hereditary Hemorrhagic Telangiectasia

Anemia

Intervention(s)

Drug: Octreotide LAR

Primary Outcome(s)

The percentage of patients who are full responder, partial responder and non-responder at the end of the treatment period [Time Frame: Comparing the 6 months before inclusion and the study period (26 weeks)]

Secondary Outcome(s)

The percentual decrease in blood and iron requirements [Time Frame: Comparing the 6 months prior to inclusion and the treatment period of 6 months.]

The percentual decrease in the number of endoscopic interventions [Time Frame: Comparing the 6 months prior to inclusion and the treatment period of 6 months.]

The number, type and severity of adverse events [Time Frame: Study period]

The mean/median decrease on the epistaxis severity score (ESS) [Time Frame: Comparing the 6 months prior to inclusion and the treatment period of 6 months.]

Change in quality of life using the Short Form (SF)-36 questionnaire [Time Frame: Comparing baseline and end of treatment visit]

Secondary ID(s)

NLROW.1012.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Antonius Hospital