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Virus Therapy
Bacteriophage Therapy for Cystic Fibrosis
Phase 1 & 2
Waitlist Available
Research Sponsored by BiomX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
Must not have
Receipt of prior bacteriophage therapy within the 6 months prior to Screening
Currently receiving treatment for allergic bronchopulmonary aspergillosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Summary
This trial is testing if a new drug is safe and if it can help reduce infection in people with CF.
Who is the study for?
Adults over 18 with cystic fibrosis and chronic lung infection caused by Pseudomonas aeruginosa can join. They must be clinically stable, able to produce sputum samples, and have a certain level of lung function (FEV1 ≥ 40%). Excluded are those with severe immune issues, prior bacteriophage therapy within six months, specific ongoing treatments for other conditions, or recent changes in CF modulator therapy.
What is being tested?
The trial is testing BX004-A, a nebulized bacteriophage therapy against a placebo. The main goal is to check if it's safe and tolerable for patients. Researchers will also explore whether this treatment reduces the amount of Pseudomonas bacteria in the lungs.
What are the potential side effects?
While not specified here, common side effects from similar therapies may include respiratory symptoms like coughing or wheezing due to inhalation of the substance; allergic reactions; fatigue; and gastrointestinal discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have cystic fibrosis with a chronic lung infection due to Pseudomonas aeruginosa and am on standard CF treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had bacteriophage therapy in the last 6 months.
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I am currently being treated for a lung fungus allergy.
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I have had severe low white blood cell counts.
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I have had a lung transplant.
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I am currently being treated for a non-tuberculous mycobacteria infection.
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I have had a solid organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability
Other study objectives
PsA burden in sputum at various timepoints
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BX004-AExperimental Treatment1 Intervention
Participants will be randomized to receive standard dose of nebulized bacteriophage
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive nebulized placebo
Find a Location
Who is running the clinical trial?
BiomX, Inc.Lead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Xilla Ussery, MDStudy DirectorBiomX, Inc.
Urania Rappo, MDStudy DirectorBiomX, Inc.
5 Previous Clinical Trials
749 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had severe low white blood cell counts.You are allergic to bacteriophages or other ingredients in the medicine.I have had a lung transplant.My lung condition is currently stable.I am currently being treated for a lung fungus allergy.I have not had bacteriophage therapy in the last 6 months.You have a weakened immune system.I am 18 years old or older.I am currently being treated for a non-tuberculous mycobacteria infection.I have had a solid organ transplant.You have been diagnosed with a Burkholderia species infection in your respiratory tract within the last year.I started or changed my cystic fibrosis treatment less than 3 months ago.I have cystic fibrosis with a chronic lung infection due to Pseudomonas aeruginosa and am on standard CF treatments.Your lung function (FEV1) is at least 40% of what is expected for someone your age and size.
Research Study Groups:
This trial has the following groups:- Group 1: BX004-A
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.