L-10 for Hemorrhagic Cystitis
A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability and Efficacy of LP-10 in Subjects with Refractory Moderate to Severe Hemorrhagic Cystitis (HC)
Inclusion Criteria:
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History of sterile moderate to severe HC (G 2-4) for at least three months documented in the medical record with at least one episode of hematuria with or without clot
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Patients with refractory HC who have previous use of medications and/or treatment(s) with no HC symptom relief
Exclusion Criteria:
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Patients currently taking prescribed treatment for HC
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Patient with history of intravesical treatment within one week prior to Study Visit 1
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Active or previous participation in another clinical trial within three months of screening
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Patients with hyperkalemia, CKD, congenital long QT syndrome, immunosuppressive therapy, interstitial cystitis/bladder pain syndrome, active cancer, PSA > 4ng/dl, and uncontrolled hypertension
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Active bleeding peptic ulcer disease
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History of bleeding diathesis
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Life expectancy less than 12 months