NCT05017662

A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072

A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ariceum Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.

Detailed description

The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
OTHER	Data collection	Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.

Timeline

• Start date: 2021-09-14
• Primary completion: 2025-04-29
• Completion: 2025-04-29
• First posted: 2021-08-24
• Last updated: 2025-09-04

Locations

7 sites across 6 countries: Australia, Austria, Denmark, France, Switzerland, United Kingdom