Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis

The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).

Inclusion Criteria:

• Ages 18 or older
• Previously established diagnosis of primary sclerosing cholangitis

Exclusion Criteria:

• American Society of Anesthesiologists class 4 or greater
• Serum creatinine >= 1.7 mg/dL, eGFR <= 30 mL/min, or dialysis dependence
• Serum hemoglobin <= 7 g
• Left ventricular ejection fraction <= 30%
• Dyspnea with minimal exertion (or supplemental oxygen dependence)
• History of bone marrow disease
• Prior recipient of organ transplantation
• Ongoing chemotherapy
• Obstruction of the upper GI tract
• Pregnant or lactating
• Inability to provide informed consent