Clinical Trial: A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation

Brief Summary: To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation

Detailed Summary:
Sponsor: Eisai Co., Ltd.

Current Primary Outcome: Success Rate of Embolization in the Target Vessel [ Time Frame: Day 1 (embolization) up to Day 30 after treatment ]

Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.


Original Primary Outcome: To evaluate the efficacy of study device with E7040, success rate of embolization in the target vessel and operability of transcatheter arterial embolization [ Time Frame: up to 12 weeks after the treatment start ]

Current Secondary Outcome: Success Rate for Operability of Embolization [ Time Frame: Day 1 (embolization) up to Day 30 after treatment ]

Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.


Original Secondary Outcome:

Information By: Eisai Inc.

Dates:
Date Received: August 30, 2012
Date Started: August 2012
Date Completion:
Last Updated: January 25, 2016
Last Verified: January 2016