We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874326
Recruitment Status : Unknown
Verified April 2018 by Radboud University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : August 22, 2016
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
St. Antonius Hospital
Information provided by (Responsible Party):
Radboud University Medical Center

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date April 20, 2018
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
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) ]
Full responder: no endoscopy and no blood/iron transfusions during treatment period.
  • Partial responder: a decrease in number of blood/iron transfusions and/or endoscopy during the treatment period compared with the 6 months prior to inclusion.
  • Non-responder: no decrease in number of blood/iron transfusions and endoscopy during the treatment period compared with the 6 months prior to inclusion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • 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 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. ]
    Comparing baseline and the end of treatment visit (week 26)
  • Change in quality of life using the Short Form (SF)-36 questionnaire [ Time Frame: Comparing baseline and end of treatment visit ]
  • The number, type and severity of adverse events [ Time Frame: Study period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • 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 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. ]
    Comparing baseline and the end of treatment visit (week 26)
  • Change in quality of life using the SF-36 questionnaire [ Time Frame: Comparing baseline and end of treatment visit ]
  • The number, type and severity of adverse events [ Time Frame: Study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Octreotide in Patients With GI Bleeding Due to Rendu-Osler-Weber
Official Title  ICMJE 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
Brief Summary

The purpose of this study is to determine whether long-acting octreotide is safe and effective in the treatment of patients with Rendu-Osler-Weber (e.g. HHT).

The study hypothesis is that octreotide is safe and will reduce transfusion requirements and endoscopy frequency in ROW patients with refractory anaemia due to bleeding gastrointestinal telangiectasias.

Detailed Description

Rationale: Rendu-Osler-Weber (ROW) is an autosomal dominant hereditary disease which affects 1 / 5-8000 individuals. It is characterized by arteriovenous malformations (AVMs) and telangiectasias in multiple organs, including the gastrointestinal tract. Patients can be transfusion dependent due to severe gastrointestinal bleeding from those telangiectasias. Endoscopy is not as effective due to the recurrent character of the telangiectasias. Based on literature in patients with non-ROW AVMs and telangiectasias, octreotide might be beneficial for these patients to decrease their transfusion needs.

Objective: To assess the efficacy of octreotide in decreasing the need for transfusions and endoscopic intervention in patients ROW with refractory anaemia due to gastrointestinal bleeding telangiectasias.

Study design: Multicenter, open-label uncontrolled pilot study.

Study population: Patients with ROW and symptomatic gastrointestinal bleeding telangiectasias, who are transfusion and/or endoscopy dependent:

  1. Transfusion dependent: at least 2 blood and/or iron infusions in the 6 months before inclusion.
  2. Endoscopy dependent: at least one endoscopic intervention with argon plasma coagulation (APC) after the initial/first endoscopic treatment after diagnosis in the half year before inclusion or unsuitable for endoscopy.

Intervention: The intervention is 20 mg Sandostatin long-acting release (LAR) once every four weeks for 26 weeks on top of standard of care.

Main study parameters/endpoints: Primary outcome is response to treatment defined as:

  • complete: no endoscopic intervention or transfusion requirements
  • partial: a reduction in endoscopic intervention or transfusion requirements
  • non-response: an equal or increase in endoscopy frequency or transfusions Important secondary outcomes are the percent change in the number of rebleeds from baseline to endpoint and the number of epistaxis episodes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hereditary Hemorrhagic Telangiectasia
  • Gastrointestinal Hemorrhage
  • Anemia
Intervention  ICMJE Drug: Octreotide LAR
Other Names:
  • Sandostatin
  • Dutch registration number (RVG) 18236
  • Anatomical Therapeutic Chemical (ATC) H01CB02
Study Arms  ICMJE Experimental: Active comparator: Octreotide LAR
Sandostatin LAR Sandostatin LAR 20 mg will be administered once every 4 weeks as a intramuscular injection
Intervention: Drug: Octreotide LAR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 17, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02874326
Other Study ID Numbers  ICMJE NLROW.1012.15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Radboud University Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Radboud University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE St. Antonius Hospital
Investigators  ICMJE
Principal Investigator: Joost Drenth, MD PhD Radboud University Medical Center
PRS Account Radboud University Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP