A Phase 2 interventional study of LP-10 in Hemorrhagic Cystitis, sponsored by Lipella Pharmaceuticals, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Lipella Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
This is a multi-center, dose-ranging study including male and female subjects with refractory moderate to severe hemorrhagic cystitis as determined by a physician. A total of up to 12 subjects are anticipated and will be enrolled in study sites in the United States. Enrollment is expected to be completed within one year of initiating the study. The proposed trial will recruit 12 subjects in a dose-escalation trial where 4 subjects will be allocated into each one of three groups.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →Lipella Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Males and females, at least 18 years
Exclusion Criteria:
LP-10 (intravesical tacrolimus), 2mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed.
Drug: LP-10
LP-10 (intravesical tacrolimus), 4mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed.
Drug: LP-10
LP-10 (intravesical tacrolimus), 8mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed.
Drug: LP-10
Intravesical tacrolimus
Patient Reported Mean episodes of visible blood
Pre-post changes in mean episodes of visible blood in urine (or blood clots) on 3-day bladder diaries at baseline and primary endpoint
Time frame: At every patient visit, up to 2 weeks following initial treatment
Urine Dipstick Mean episodes of Visible Blood
Mean episodes of visible blood in urine (or blood clots) and urine dipstick for quantitative grading of microscopic hematuria on bladder diaries
Time frame: At every patient visit, up to 2 weeks following initial treatment
Mean urine hemoglobin concentration
Mean urine hemoglobin concentration
Time frame: At every patient visit, up to 2 weeks following initial treatment
Urine analysis with microscopy
Urine analysis with microscopy including red blood cells per high power field test
Time frame: At every patient visit, up to 2 weeks following initial treatment
Whole blood Add to dictionary levels
Whole blood tacrolimus levels
Time frame: At every patient visit, up to 2 weeks following initial treatment
Blood chemistry and liver function test
Blood chemistry and liver function test
Time frame: At every patient visit, up to 2 weeks following initial treatment
Patient Reported Global Response Assessment Survey Score
Changes in Global Response Assessment (GRA)
Time frame: At every patient visit, up to 2 weeks following initial treatment
Patient Reported Urinary frequency
Changes in urinary frequency and incontinence measured on diaries
Time frame: At every patient visit, up to 2 weeks following initial treatment
Bladder Cystoscopy
Cystoscopic changes in bladder
Time frame: At initial treatment and on final patient visit, up to 2 weeks following initial treatment
Patient Reported Health Related Quality of Life Survey Score
Changes in Health Related Quality of Life (HRQOL) scores
Time frame: At every patient visit, up to 2 weeks following initial treatment
Post void residual urine volume
Post void residual urine volume
Time frame: At every patient visit, up to 2 weeks following initial treatment
Patient Reported Pain and Urgency
Change in pain and urgency 10 cm visual analog scales (VAS)
Time frame: At every patient visit, up to 2 weeks following initial treatment
Incidence of Treatment-Emergent Adverse Events
Safety data will be collected by ongoing monitoring of adverse events, during the entire duration of the study, including need for blood transfusion, bladder irrigation, emergency room visit, hospitalization, urinary catheterization, and/or surgery in addition to patient reporting of changes in urinary frequency, hematuria/ clots, incontinence, spasm or discomfort.
Time frame: At every patient visit, up to 2 weeks following initial treatment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Lipella Pharmaceuticals, Inc.