NCT02948842

Clostridium Histolyticum Collagenase Injection for Urethral Disease

Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.

Detailed description

This is an open-label, pilot study to explore the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures. Subjects will be followed for 2 years from the initial drug treatment.

Conditions

• Urethral Stricture

Interventions

Type	Name	Description
DRUG	Clostridium Histolyticum Collagenase	0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring.
OTHER	Saline	0.08ml of injectable normal saline

Timeline

• Start date: 2020-05-22
• Primary completion: 2023-03-04
• Completion: 2023-04-12
• First posted: 2016-10-28
• Last updated: 2023-11-03
• Results posted: 2023-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study