The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis
NCT ID: NCT03129126
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2020-10-01
2023-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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LP-10 2mg
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.
LP-10
Intravesical tacrolimus
LP-10 4mg
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.
LP-10
Intravesical tacrolimus
LP-10 8mg
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.
LP-10
Intravesical tacrolimus
Interventions
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LP-10
Intravesical tacrolimus
Eligibility Criteria
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Inclusion Criteria
* History of sterile moderate to severe HC (Grade 2-4) for at least 3 months documented in the medical record with at least 1 episode of macroscopic hematuria with or without clot
* Previous use of medications and/or treatment(s) for HC without success
* Patients of child-bearing capability agree to use a reliable form of birth control (condoms and/or oral contraceptives) during the course of instillation therapy and for 1 week thereafter
* Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the 3 day Hemorrhagic Cystitis Diary (HC Diary) and self-administered questionnaires
Exclusion Criteria
* HC due to infection (bacterial, viral or fungal)
* Vesicoureteral reflux disease based on cystogram within past 12 months
* Subject is currently or has previously participated in another therapeutic or device study within 3 months of screening and has not returned to baseline
* Pregnant or lactating
* History of bleeding diathesis or active bleeding peptic ulcer disease
* Life expectancy less than 12 months
* PSA \> 10.0 ng/dl (measured within the last 3 months)
* Known allergy to liposomes and/or egg yolk and/or tacrolimus
* Urinary retention requiring daily catheterization
* Previous augmentation cystoplasty
* Subjects currently taking prescribed treatment for HC will be able to continue the treatment throughout the course of the study. If the patient cannot be maintained on a stable dose of the medication(s) throughout the treatment and follow-up period they will be excluded
* Subject with history of intravesical treatment(s) within 1 week prior to Study Visit 1
* Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting.
* Evidence of renal impairment (creatinine \> two times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT \> three times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment
* Post-void residual (PVR) urine volume of \> 150 mL at screening
* The presence of any clinically significant systemic disease or condition that in the opinion of the investigator would make the patient unsuitable for the study
18 Years
ALL
No
Sponsors
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Lipella Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Arizona
Tucson, Arizona, United States
University of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Michigan Institute of Urology
Troy, Michigan, United States
Premier Medical Group
Poughkeepsie, New York, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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Safety and Efficacy of LP-10
Identifier Type: -
Identifier Source: org_study_id