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NCT07301320 · ClinicalTrials.gov registry record · Phase 2
Epetraborole in Patients With Mycobacterium Abscessus Lung Disease
A Phase 2 study, sponsored by Kevin Winthrop.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT07301320 is a Phase 2 study that is actively recruiting participants, run by Kevin Winthrop. The registered enrollment target is 84 participants.
The verdict
NCT07301320, a Phase 2 study, is actively recruiting participants, sponsored by Kevin Winthrop.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study, two EBO oral dose regimens will be studied in patients with MABc-LD, each compared to a placebo group (ie, 4 treatment groups): 500 mg daily and 750 mg daily. Detailed inclusion and exclusion criteria attempt to identify only those patients who have acceptable risks based upon the EBO preclinical findings, phase 1, phase 2, and Phase 3 experience; standard-of-care procedures; and the specified procedures of the study. Following receipt of informed consent, and a Screening period, eligible patients will be randomized to one of the 4 treatment groups to receive active or matched placebo EBO tablets for 84 days. Patients will be assessed for clinical and microbiological evidence of efficacy. At selected investigative sites, patients will undergo sparse PK sampling. Safety and tolerability will be determined by standard clinical and laboratory assessment, with oversight by a qualified and appropriately constituted Data Safety Monitoring Board (DSMB). Data collected during the study will be analyzed per a comprehensive Statistical Analysis Plan (SAP). The study will be registered on clinicaltrials.gov. The total duration of patient participation is approximately 6 months.
Interventions
- DRUG Placebo
- DRUG Epetraborole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2026-03-30 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07301320
The ClinicalTrials.gov registry entry for NCT07301320 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kevin Winthrop, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07301320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07301320 about?
NCT07301320 is a clinical study titled "Epetraborole in Patients With Mycobacterium Abscessus Lung Disease". This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study...
What is the current status of trial NCT07301320?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2026-03-30. Estimated completion is 2028-05.
What interventions are being tested in trial NCT07301320?
The interventions under investigation include: Placebo (DRUG), Epetraborole (DRUG).
Who is sponsoring clinical trial NCT07301320?
This trial is sponsored by Kevin Winthrop, which has 5 total clinical trials registered on ClinicalTrials.gov.
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