NCT04684641

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY): A Single-site, Randomized, Double-blind, Placebo-controlled Study of Bacteriophage Therapy YPT-01 for Pseudomonas Aeruginosa Infections in Adults With Cystic Fibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study with primary objective of looking whether YPT-01 phage therapy reduces sputum bacterial load in cystic fibrosis subjects with Pseudomonas aeruginosa. In addition, study evaluates the safety profile of phage therapy in this patient population.

Detailed description

This is a prospective, randomized, placebo-controlled, double-blinded, single-site study of Yale Phage Therapy (YPT) 01 in cystic fibrosis subjects with chronic Pseudomonas aeruginosa airway infections. The study has 2 parallel arms of phage therapy and placebo, with all study materials GMP-manufactured. The purpose of this study is to demonstrate efficacy and safety of inhaled (nebulized) phage therapy YPT-01. Clinically stable subjects who have confirmed diagnosis of CF with PsA in sputum cultures on at least two occasions within past year, and in sputum at screening visit, will be recruited into this study. An open-label extension is available for subjects in the placebo group to receive YPT-01 following completion of blinded portion of the study. Nov 2022 study ended enrollment after 8 subjects. The Double-Blind Randomized portion of the study was closed and the Open-Label Extension was opened.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Standard Dose YPT-01	Participants will be randomized to receive the standard dose of phage therapy YPT-01.
OTHER	Placebo	Participants will be randomized to receive the placebo.

Timeline

• Start date: 2021-03-29
• Primary completion: 2023-05-26
• Completion: 2023-06-22
• First posted: 2020-12-24
• Last updated: 2023-11-18
• Results posted: 2023-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study