Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Li, Zhiping, M.D.
• Collaborator: Johns Hopkins University
• Treatments: Mitomycin; Mitomycins

Criteria

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