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NCT03129126 · ClinicalTrials.gov registry record · Phase 2
The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis
A Phase 2 study, sponsored by Lipella Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03129126: Completed Phase 2 study, sponsored by Lipella Pharmaceuticals.
NCT03129126 is a Phase 2 study that has completed, run by Lipella Pharmaceuticals. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03129126, a Phase 2 study, has completed, sponsored by Lipella Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). Twelve subjects meeting the inclusion and exclusion criteria will be enrolled and treated in a prospective and multi-center trial with LP-10. The proposed trial will recruit 12 subjects in a dose-escalation trial where 4 subjects will be allocated into each one of three groups.
Primary Outcome
Pre-post changes in mean episodes of visible blood in urine (or blood clots) on 3-day bladder diaries at baseline and primary endpoint
Interventions
- DRUG LP-10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 2 |
What the finished NCT03129126 record still lists
NCT03129126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which LP-10 is the first listed.
NCT03129126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03129126 about?
NCT03129126 is a clinical study titled "The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis". The purpose of this study is to assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). Twelve subjects meeting the inclusion and exclusion criteria will be enrolled and treated in a prospective and multi-center trial with LP-10. The proposed trial will recruit 12 subje...
What is the current status of trial NCT03129126?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2020-10-01. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT03129126?
The interventions under investigation include: LP-10 (DRUG).
Who is sponsoring clinical trial NCT03129126?
This trial is sponsored by Lipella Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03129126's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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