Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

Li, Zhiping, M.D.

Status and phase: Unknown; Phase 2

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: Normal saline; Drug: Mitomycin C

Study type: Interventional

Funder types: Other

Identifiers

NCT01688024

NA_00052685

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

Mitomycin C

Experimental group

Description:

Up to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given.

Treatment:

Drug: Mitomycin C

Normal saline

Placebo Comparator group

Description:

Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed.

Treatment:

Drug: Normal saline