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CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)

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ClinicalTrials.gov Identifier: NCT04684641
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Jonathan Koff, Yale University

Brief 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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Standard Dose YPT-01 Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Phage therapy
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Drug: Standard Dose YPT-01
Participants will be randomized to receive the standard dose of phage therapy YPT-01.
Other Name: Phage Therapy

Active Comparator: Placebo
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Other: Placebo
Participants will be randomized to receive the placebo.




Primary Outcome Measures :
  1. Reduction in sputum bacterial culture [ Time Frame: Day 14 ]
    Reduction in sputum bacterial culture titers of Pseudomonas as measured by colony forming units/mL at day 14


Secondary Outcome Measures :
  1. Change in lung function [ Time Frame: Baseline, day 14, day 21, day 28, and day 56 ]
    Compare lung function [percent predicted forced expiratory volume in 1 second (FEV1pp)] in subjects randomized to phage therapy and placebo at day 14, 21, 28, and 56

  2. Change in the rate of pulmonary exacerbations [ Time Frame: Baseline, day 56 ]
    Compare the rates of pulmonary exacerbations between subjects randomized to phage therapy versus placebo during the first 56 days of the study

  3. Change in the rate of hospitalization [ Time Frame: Baseline, day 56 ]
    Compare the rates of hospitalizations between subjects randomized to phage therapy versus placebo during the first 56 days of the study

  4. Change in the rate of acute antibiotic use [ Time Frame: Baseline, day 56 ]
    Compare the rates of acute antibiotic use between subjects randomized to phage therapy versus placebo during the first 56 days of the study

  5. Patient's Quality of Life [ Time Frame: Baseline, day 56 ]
    Compare the changes in subject-reported quality of life, using the CFQR, between subjects randomized to phage therapy versus placebo during the first 56 days of the study. This survey consists of 50 questions that relate to a subjects clinical condition and mental health. Administration time takes 10 minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Capable of giving signed informed consent;
  2. Stated willingness to comply with all study procedures and availability for the duration of the study;
  3. Age ≥18;
  4. CF diagnosis based upon genetics, sweat chloride testing, or clinical manifestations;
  5. Able to provide repeated induced sputum samples;
  6. Able to use a nebulizer;
  7. PsA culture positive on two occasions within past 2 years and in sputum at screening visit;
  8. FEV1 >40% and <100% predicted;
  9. Clinically stable lung disease, defined as no decrease in FEV1 >10% or pulmonary exacerbations in the 4 weeks prior to screening;
  10. If on CF modulator therapy (e.g., ivacaftor, ivacaftor/elexacaftor/tezacaftor), then subject remains on the same modulator therapy for at least 2 months prior to enrollment;
  11. For females of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use 2 methods of effective contraception during study participation and for an additional 6 weeks after the end of YPT-01 administration;
  12. Males of non-reproductive potential (e.g., documented congenital bilateral absence of vas deferens) or males of reproductive potential (e.g., non-vasectomized males or males vasectomized less than 120 days prior to study start) that agree to use condoms with spermicide while engaging in sexual activity or be sexually abstinent.

Exclusion Criteria:

  1. History of solid organ transplant (e.g., lung or liver);
  2. Severe neutropenia, as defined by absolute neutrophil count (ANC) of < 500 per microliter;
  3. No YPT-01 phage identified that effectively targets sputum PsA;
  4. Prior treatment with phage therapy of any kind;
  5. Treatment for pulmonary exacerbation within the prior 4 weeks;
  6. Change in pulmonary medications within the prior 4 weeks;
  7. Subjects who are pregnant, who intend to become pregnant, or who do not wish to use contraception;
  8. Subjects who are breastfeeding;
  9. Participation in another clinical research study concurrently or within the prior 2 months;
  10. Known allergy to soy, egg, yeast, or meat.
  11. Any genetic or acquired (including medication-induced) immunocompromised condition, beyond the level of immunocompromise typically associated with CF and its management.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684641


Contacts
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Contact: Jonathan Koff, MD +1 (203) 737-6963 jon.koff@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jon Koff, MD    203-737-6963    jon.koff@yale.edu   
Principal Investigator: Jon Koff, MD         
Sponsors and Collaborators
Yale University
Investigators
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Study Director: Jonathan Koff, MD Yale University
Principal Investigator: Benjamin Chan, PhD Yale University
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Responsible Party: Jonathan Koff, Director, Adult Cystic Fibrosis Program, Yale University
ClinicalTrials.gov Identifier: NCT04684641    
Other Study ID Numbers: 2000029160
20-004179 ( Other Grant/Funding Number: Cystic Fibrosis Foundation (CFF) )
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Koff, Yale University:
Pseudomonas
bacteriophage
phage
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases