The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis
Hemorrhagic Cystitis
About this trial
This is an interventional treatment trial for Hemorrhagic Cystitis
Eligibility Criteria
Inclusion Criteria:
Males and females, at least 18 years
- 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:
- History of interstitial cystitis/painful bladder syndrome
- 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
Sites / Locations
- University of Arizona
- University of California San Francisco
- Emory University
- Michigan Institute of Urology
- Premier Medical Group
- Temple University
- Allegheny Health Network Research Institute
- Vanderbilt University Medical Center
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
LP-10 2mg
LP-10 4mg
LP-10 8mg
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), 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), 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.