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NCT Number: NCT05453578

A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This clinical trial is designed to assess the safety and microbiological activity of bacteriophage product Walter Reed Army Institute of Research- PAM-Cystic Fibrosis1 (WRAIR-PAM-CF1), directed at Pseudomonas aeruginosa in clinically stable CF individuals chronically colonized with P. aeruginosa. WRAIR-PAM-CF1 is a 4 component anti-pseudomonal bacteriophage mixture containing between 4 x 10^7 and 4 x 10^9 Plaque Forming Units (PFU) of bacteriophage. Enrollment will occur at up to 20 clinical sites in the United States. In stage 1, two eligible subjects will be assigned to each of the three dosing arms receiving a single dosage of the IV bacteriophage therapy (4 x 10^7 PFU, 4 x 10^8 PFU, and 4 x 10^9 PFU; total of 6 sentinel subjects), followed by 30 plus or minus 7 days observation period. If no Serious Adverse Events (SAEs)(related to the study product) are identified during the 96 hours after bacteriophage administration for all Sentinel Subjects in Stage 1, the study will proceed to Stage 2. In Stage 2a, 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 10^7 PFU, 4 x 10^8 PFU, and 4 x 10^9 PFU) in a 1:1:1:1 allocation. An interim analysis will be performed after all subjects have completed follow up visit 5 on Day 8+3 to select the IV bacteriophage dose with the most favorable safety and microbiological activity profile. During Stage 2b, subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b bacteriophage dose.

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Key information

Conditions

Bacterial Disease Carrier Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Pseudomonas Infections Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Arizona - Banner University Medical Center Tucson Campus - Tucson, Tucson, Arizona, United States

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About this study

This is a phase 1b/2, multicenter, randomized placebo-controlled double-blind study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This clinical trial is designed to assess the safety and microbiological activity of bacteriophage product Walter Reed Army Institute of Research- PAM-Cystic Fibrosis1 (WRAIR-PAM-CF1), directed at Pseudomonas aeruginosa (P. aeruginosa) in clinically stable CF individuals chronically colonized with P. aeruginosa. WRAIR-PAM-CF1 is a 4 component anti-pseudomonal bacteriophage mixture containing between 4 x 10^7 and 4 x 10^9 Plaque Forming Units (PFU) of bacteriophage. Enrollment will occur at up to 20 clinical sites in the United States. In stage 1, two sentinel subjects will be assigned to each of the three dosing arms receiving a single dosage of the IV bacteriophage therapy (4 x 10^7 PFU, 4 x 10^8 PFU, and 4 x 10^9 PFU; total of 6 sentinel subjects), followed by 30 plus or minus 7 days observation period. If no Serious Adverse Events (SAEs) (related to the study product) are identified during the 96 hours after bacteriophage administration for all Sentinel Subjects in Stage 1, the study will proceed to Stage 2. In Stage 2a, 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 10^7 PFU, 4 x 10^8 PFU, and 4 x 10^9 PFU) in a 1:1:1:1 allocation. An interim analysis will be performed after all subjects have completed follow up visit 5 on Day 8+3 to select the IV bacteriophage dose with the most favorable safety and microbiological activity profile. During Stage 2b, subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b bacteriophage dose. The primary objectives of this study are to 1) describe the safety of a single dose of IV bacteriophage therapy in clinically stable CF subjects with P. aeruginosa in expectorated sputum; 2) describe the microbiological activity of a single dose of IV bacteriophage therapy in clinically stable CF subjects with P. aeruginosa in expectorated sputum; 3) describe the benefit to risk profile of a single dose of IV bacteriophage therapy in clinically stable CF subjects with P. aeruginosa in expectorated sputum.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all the inclusion criteria to be eligible to participate in the study:

  • Adult (>/= 18 years) at the time of screening.
  • Confirmed Cystic Fibrosis (CF) diagnosis based on a compatible clinical syndrome confirmed by either an abnormal sweat chloride testing or CFTR gene variations.*

*Can be obtained from documentation in medical records; actual test results not necessary.

  • Likely able to produce at least 2 mL of sputum during a 30-minute sputum collection following a hypertonic saline treatment or other approach to increase sputum production.**

**Determined by investigator or their designee judgement. Approaches for obtaining sputum may include, but are not limited to, inhaled hypertonic saline (e.g., 3%, 7%, or 10%), inhaled hypertonic bicarbonate, inhaled mannitol, or spontaneously expectorated sputum. The same approach is recommended, whenever possible, for all sputum collections for a given subject.

  • Pseudomonas aeruginosa (regardless of Colony Forming Units (CFU)/mL) isolated from a sputum, throat culture, or other respiratory specimen in the past 12 months.
  • Confirmed P. aeruginosa isolation from a sample of expectorated sputum at the Screening Visit.
  • Capable of providing informed consent.
  • Capable and willing to complete all study visits and perform all procedures required by the protocol.

Exclusion criteria

Subjects who meet any of the exclusion criteria will not be enrolled in the study:

  • Body weight < 30 kg.
  • Forced Expiratory Volume in 1 second (FEV1) < 20% of predicted value at screening, using the Hankinson equations.
  • Elevated Elevated liver function tests (LFTs) obtained at screening.*

*a. Alanine aminotransferase (ALT) > 5 x the upper limit of normal (ULN) or aspartate transaminase (AST) > 5 x ULN or total bilirubin > 3 x ULN, OR b. Total bilirubin > 1.5 x ULN combined with either ALT > 3 x ULN or AST > 3 x ULN. ULN reflects local laboratory ranges.

  • Acute clinical illness requiring a new (oral, parenteral), or inhaled antibiotic(s) </= 30 days prior to the baseline visit.*

*Does not include chronic suppressive medications or cyclic dosing medications such as inhaled antibiotics.

  • Women who are pregnant, planning to become pregnant during the study period, or breastfeeding.* *Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin test during screening and agree to use an effective method of contraception for the duration of the trial.*

*A female is considered of childbearing potential unless postmenopausal, or surgically sterilized and at least 3 months has passed since sterilization procedure.

  • Female surgical sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, or bilateral oophorectomy.
  • Female is considered postmenopausal if she is >45 years old and has gone at least 12 months without a spontaneous menstrual period without other known or suspected cause.
  • Effective methods of contraception include (a) abstinence, (b) partner vasectomy, (c) intrauterine devices, (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).
  • Active treatment of any mycobacterial or fungal organisms </=30 days prior to baseline. Chronic treatment for suppression of fungal populations is allowable.
  • Anticipated need to change chronic antibiotic regimens during the study period.*

*Subjects on cyclic dosing medications such as inhaled antibiotics, must be able and express willingness to keep the therapies at the time of screening constant (either remain on the therapy or not remain on the therapy) for the duration of the follow-up period (approximately 30 days). Subjects on chronic suppressive antimicrobial therapy must be able and express willingness to stay on the therapies for the duration of their follow-up period. This includes chronic azithromycin therapy.

  • Known allergy to any component of the study product.
  • Any significant finding that, in the opinion of the investigator, would make it unsafe for the subject to participate in this study.
  • Enrolled in a clinical trial within </=30 days of the baseline/dosing visit, or participating in a clinical trial while enrolled in this clinical trial (inclusive of vaccine trials).
  • Currently or previously enrolled in this trial.

Treatment and study plan

Placebo

Other

0.9 percent sodium chloride

WRAIR-PAM-CF1

Biological

Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.

Primary outcomes

  1. Number of Participants That Experienced Grade 2 or Higher Treatment-emergent Adverse Events in the ITT Population

    Time frame: Day 1 through Day 30

    An event that occurred during the treatment period was considered a treatment-emergent AE if it was not present before the first dose of investigational product or was present before the first dose of investigational product and increased in severity during the treatment period.

  2. Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b

    Time frame: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30

    Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are substituted with the limit of detection (LOD) of the assay (1 x 10^4 CFU/mL).

  3. Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b

    Time frame: Day 1 Post-infusion, Day 2, Day 5, and Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10^4 CFU/mL)

  4. Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b

    Time frame: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30

    Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are treated as missing.

  5. Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b

    Time frame: Day 1 Post-infusion, Day 2, Day 5, and Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

    Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

    Rank 4 = SAE (related to study product).

    The DOOR probability is estimated using:

    Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.

  6. Number of Susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10^4 CFU/mL)

  7. Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).

  8. Number of Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).

  9. Number of Not Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).

  10. Number of Susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

    Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

    Rank 4 = SAE (related to study product).

    The DOOR probability is estimated using:

    Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.

  11. Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

    Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

    Rank 4 = SAE (related to study product).

    The DOOR probability is estimated using:

    Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.

  12. Number of Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

    Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

    Rank 4 = SAE (related to study product).

    The DOOR probability is estimated using:

    Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.

  13. Number of Not Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit

    Time frame: Baseline through Day 8

    A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

    Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

    Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

    Rank 4 = SAE (related to study product).

    The DOOR probability is estimated using:

    Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2022
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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