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Virus Therapy

Standard Dose YPT-01 for Cystic Fibrosis

Phase 1 & 2

Waitlist Available

Led By Benjamin Chan, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, day 14, day 21, day 28, and day 56

Awards & highlights

Study Summary

This trial is testing whether a new therapy can reduce the amount of bacteria in the lungs of people with cystic fibrosis. The therapy is safe for this population.

Eligible Conditions

Cystic Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, day 14, day 21, day 28, and day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, day 14, day 21, day 28, and day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, day 14, day 21, day 28, and day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Sputum Bacterial Culture

Secondary outcome measures

Change in Lung Function

Difference in the Rate of Acute Antibiotic Use

Difference in the Rate of Hospitalization

+2 more

Side effects data

From 2023 Phase 1 & 2 trial • 8 Patients • NCT04684641

50%

Dizziness

25%

Bruising and swelling at blood draw site

25%

COVID-19 Positive

25%

CF-Related Pulmonary Exacerbation

25%

Back Pain

25%

Fatigue

25%

Nasal Congestion

25%

Non-cardiac chest pain

25%

Productive cough

25%

Bruised Toe

25%

Cough

25%

Hemoptysis

25%

Kidney Stones

25%

Headache

25%

Sore throat

25%

Weight gain

100%

80%

60%

40%

20%

Study treatment Arm

Phage Therapy

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Phage therapyExperimental Treatment1 Intervention

Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.

Group II: PlaceboActive Control1 Intervention

Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard Dose YPT-01

2021

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,660 Total Patients Enrolled

2 Trials studying Cystic Fibrosis

47 Patients Enrolled for Cystic Fibrosis

Jonathan Koff, MDStudy Director - Yale University

Yale University

Benjamin Chan, PhDPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant enrollment for this experiment?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial is actively seeking participants. It was initially posted on March 29th 2021 and has been recently updated as of August 23rd 2022. The objective is to sign up 36 individuals at a single site."

Answered by AI

Is enrollment currently underway for this research initiative?

"Data hosted on clinicaltrials.gov affirms that this medical trial, which was placed online at the end of March 2021, is currently inviting participants to join. The most recent update was posted in August 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)

Jonathan Koff 2021. "CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684641.