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NCT01034176 · ClinicalTrials.gov registry record · Phase 4
BK Treatment Study
A Phase 4 study of BK Viremia, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
- 8
- Study locations
NCT01034176: Completed Phase 4 study of BK Viremia, sponsored by Brigham and Women's Hospital.
NCT01034176 is a Phase 4 study of BK Viremia that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01034176, a Phase 4 study of BK Viremia, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
- 8
- Study locations
Study Summary
Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients with persistent viremia (BK virus found in blood) will impair progress to BK virus induced kidney damage by significantly decreasing or eliminating BK virus in the blood.
Primary Outcome
Percent change in BK virus copies/mL from Baseline to 3 months
Conditions Studied
Interventions
- DRUG placebo
- DRUG levofloxacin
Study Locations (8)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Lahey Clinic Medical Center - Burlington
- UMASS Memorial Medical Center - Worcester
New York
- Montefiore Medical Center - The Bronx
Vermont
- Fletcher Allen Health Care/University of Vermont - Burlington
Wisconsin
- University of Wisconsin Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-10 |
| Phase | Phase 4 |
What the finished NCT01034176 record still lists
NCT01034176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with BK Viremia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01034176 lists 8 locations in 4 states (Massachusetts, New York, Vermont).
Frequently Asked Questions
What is clinical trial NCT01034176 about?
NCT01034176 is a clinical study titled "BK Treatment Study". Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients with persistent viremia (BK virus found in blood) will impair progress to BK virus induced kidney damage by significantly decreasing or eliminating BK virus in the blood.
What is the current status of trial NCT01034176?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2009-02. Estimated completion is 2012-10.
What conditions does trial NCT01034176 study?
This clinical trial studies the following conditions: BK Viremia.
What interventions are being tested in trial NCT01034176?
The interventions under investigation include: placebo (DRUG), levofloxacin (DRUG).
Who is sponsoring clinical trial NCT01034176?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01034176 being conducted?
This trial has 8 study locations across Massachusetts, New York, Vermont, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01034176's enrollment target sits among peer trials
43 1371st of 2000 higher than 622 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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