Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

Status unconfirmed · Phase 2

Conditions studied: Primary Sclerosing Cholangitis

In brief

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

Key facts

Study ID

NCT01688024

Run by

Li, Zhiping, M.D.

People needed

130

Starts

2012-09-01

Expected to finish

2019-09-01

Last updated by the study team

2016-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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