Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

Phase 2

• Conditions: Primary Sclerosing Cholangitis
• Interventions: Drug: Normal saline; Drug: Mitomycin C

• Registration Number: NCT01688024
• Lead Sponsor: Li, Zhiping, M.D.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07
• Primary Completion: 2017-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis	Two years

Secondary Outcome Measures

Name	Time	Method
Number of Patients with Adverse Events	Two years
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications	Two years

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States