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Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). Twelve subjects meeting the inclusion and exclusion criteria will be enrolled and treated in a prospective and multi-center trial with LP-10. The proposed trial will recruit 12 subjects in a dose-escalation trial where 4 subjects will be allocated into each one of three groups.


Clinical Trial Description

This is a multi-center, dose-ranging study including male and female subjects with refractory moderate to severe hemorrhagic cystitis as determined by a physician. A total of up to 12 subjects are anticipated and will be enrolled in study sites in the United States. Enrollment is expected to be completed within one year of initiating the study. The proposed trial will recruit 12 subjects in a dose-escalation trial where 4 subjects will be allocated into each one of three groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03129126
Study type Interventional
Source Lipella Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date October 1, 2020
Completion date September 29, 2023

See also
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