The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis

Open to people ages 18 years and up

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

• 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