A study for evaluation of efficacy and safety of ethanolamine oleate in patients with venous malformations

Phase 3

• Conditions: Venous malformation difficult to remove

• Registration Number: JPRN-jRCT2051200046
• Lead Sponsor: omura Tadashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. No age limitation
2. Signed informed consent from patient or legal guardian(s) (In case age of patient is under 20 years old)
3. Venous malformations are considered difficult to remove, and sclerotherapy is considered first line treatment option by investigator/sub-investigator. Difficulty to remove means a high risk of functional dysfunction due to excision, or a loss of appearance to affect in daily life.
4. Patients who have one or more target venous malformations with a major axis of 30 mm or more in extremities, and 20 mm or more in head and neck region on MRI or CT
5. No thrombus and organized tissue that affects image evaluation or effect judgment in target venous malformations

Exclusion Criteria

1. Patients with multiple organ failure or DIC (Disseminated intravascular coagulation)
2. Patients who are taking or have taken drugs that may affect resolution of lesions (propranolol, herbal medicines [such as Kamishoyosan, Ninjinyoeito, Eppikajutsuto or Ogikenchuto], or sirolimus). However, patients can participate in the clinical study in case herbal medicines are discontinued 2 weeks or more before study drug administration.
3. Patients with diabetes mellitus with HbA1c>=8.0, or autoimmune disorder
4. Patients with liver dysfunction judged as grade C (10-15 points) in Child-Pugh classification
5. Patients with renal dysfunction with eGFR < 60mL/min/1.73m2
6. Patients with cardiac dysfunction with over grade II in NYHA classification
7. Patients having sclerotherapy within 6 months before obtaining informed consent
8. Patients with history of allergy to ethanolamine oleate or angiographic X-ray contrast agent as concomitant drugs
9. Patients having surgery over 45 minutes within 2 weeks before obtaining informed consent
10. Patients participating in other clinical study within 4 weeks before obtaining informed consent
11. Pregnant women, women who may be pregnant, or lactating women
12. Patients who are judged as inappropriate by investigator/sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified