Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias

NCT02384122 | Completed Phase 3 DMC

• 1 other identifier: NLOCEAN.50514.091.14
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to determine whether 40 mg octreotide long-acting release intramuscular every 28 days is effective in the treatment of patients with refractory anemia due to gastrointestinal angiodysplasias. We hypothesize that octreotide is effective in reducing the transfusion requirements (consisting of red blood cell transfusions and intravenous iron infusions) of patients with angiodysplasia-related anemia.

Conditions

Angiodysplasia; Vascular Malformations; Gastrointestinal Hemorrhage; Anemia

Keywords

Angiodysplasias; Sandostatin LAR; Gastrointestinal bleeding; Somatostatin analogs; Octreotide

Outcome Measures

Primary Outcomes (1)

• Difference in blood and parenteral iron requirements (transfusion units)

  The mean difference in blood (RBC transfusions per 500 ml or packed cells) and parenteral iron (IV iron infusions per 500 mg) requirements between the intervention and standard of care arm, corrected for baseline transfusion requirements and follow-up time.

  Study year (52 weeks)

Secondary Outcomes (12)

• Proportion with a good treatment response

  During the study year (52 weeks) compared to the year (52 weeks) before randomization

• Use of concomitant care

  Study year (52 weeks)

• Difference in endoscopic procedures

  Study year (52 weeks)

• Difference in bleeding episodes

  Study year (52 weeks)

• Difference in healthcare utilization

  Study year (52 weeks)

Other Outcomes (2)

• Subgroup analyses on blood transfusion dependency

  Study year (52 weeks)

• Subgroup analyses on use of antithrombotics

  Study year (52 weeks)

Study Arms (2)

Octreotide

ACTIVE COMPARATOR

Drug: Sandostatin LAR Sandostatin LAR 40 mg will be administered once every 4 weeks as a intramuscular injection

Drug: Octreotide

Standard of care

NO INTERVENTION

Patients receive standard of care without a placebo.

Interventions

Octreotide DRUG

Two injections of 20 mg will be given monthly.

Also known as: Sandostatin LAR, RVG 18236, ATC H01CB02

Octreotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endoscopically diagnosed angiodysplasias
• Failure of endoscopic therapy: at least one endoscopic attempt to coagulate the angiodysplasias or unsuitable for endoscopic procedures
• Providing informed consent
• Older than 18 years

You may not qualify if:

• Liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
• Previous treatment with octreotide for the same indication (refractory anemia due to angiodysplasias)
• Current thalidomide treatment which is effective (no transfusion dependency)
• Life expectancy \< 1 year
• Left ventricular assist devices (LVAD's)
• Hereditary hemorrhagic diseases or hematological disorders with active treatment
• Pregnancy or nursing women
• Uncontrolled diabetes as defined by HbA1C \>64 mmol/ml, despite adequate therapy
• Known hypersensitivity to somatostatin analogs
• Symptomatic cholecystolithiasis
• Systemic cancer under active treatment (chemotherapy or radiation therapy)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Jeroen Bosch Ziekenhuis: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Bernhoven Hospital: collaborator
• Tjongerschans hospital: collaborator
• Gelre Hospitals: collaborator
• Maasstad Hospital: collaborator
• Reinier de Graaf Groep: collaborator
• University Medical Center Groningen: collaborator
• Rijnstate Hospital: collaborator
• St. Antonius Hospital: collaborator

Study Sites (12)

Gelre Hospital

Apeldoorn, Gelderland, 7334 DZ, Netherlands

Location

Radboud University Medical Center (Radboudumc)

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, 5200 ME, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Elisabeth-TweeSteden Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

Rijnstate Hospital

Arnhem, 6815AD, Netherlands

Location

University Medical Center Groningen (UMCG)

Groningen, 9713GZ, Netherlands

Location

Tjongerschans Hospital

Heerenveen, 8441 PW, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Bernhoven Hospital

Uden, 5406 PT, Netherlands

Location

Related Publications (2)

• Goltstein LCMJ, Grooteman KV, Bernts LHP, Scheffer RCH, Laheij RJF, Gilissen LPL, Schrauwen RWM, Talstra NC, Zuur AT, Braat H, Hadithi M, Brouwer JT, Nagengast WB, Oort FA, Tenthof van Noorden J, Kievit W, van Geenen EJM, Drenth JPH. Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Apr;166(4):690-703. doi: 10.1053/j.gastro.2023.12.020. Epub 2023 Dec 28.

  PMID: 38158089 DERIVED

• Grooteman KV, van Geenen EJ, Drenth JP. Multicentre, open-label, randomised, parallel-group, superiority study to compare the efficacy of octreotide therapy 40 mg monthly versus standard of care in patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias: a protocol of the OCEAN trial. BMJ Open. 2016 Sep 12;6(9):e011442. doi: 10.1136/bmjopen-2016-011442.

  PMID: 27619827 DERIVED

Related Links

• Announcement of research project in the "Nederlands Tijdschrift voor Geneeskunde"

MeSH Terms

Conditions

Angiodysplasia; Vascular Malformations; Gastrointestinal Hemorrhage; Anemia

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Joost Drenth, MD. PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial was blinded for the outcome adjudication committee but not for patients or attending physicians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, open-label, randomized, parallel-group, superiority study to compare the efficacy of 40 mg octreotide long-acting release intramuscular every 28 days in addition to standard of care versus standard of care alone in patients with refractory anemia due to gastrointestinal bleeding from angiodysplasias.

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Data sharing agreement

Locations

NL (12)