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Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01688024
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Mitomycin C Drug: Normal saline Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
Study Start Date : September 2012
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2019

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Drug: Mitomycin C
Placebo Comparator: 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.
Drug: Normal saline

Outcome Measures

Primary Outcome Measures :
  1. Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Number of Patients with Adverse Events [ Time Frame: Two years ]
  2. Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications [ Time Frame: Two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688024

Contact: Po-Hung Chen, M.D. 410-502-6072 pchen37@jhmi.edu
Contact: Tinsay A. Woreta, M.D., M.P.H. 410-955-2635 tworeta1@jhmi.edu

United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21288
Principal Investigator: Zhiping Li, M.D.         
Sponsors and Collaborators
Li, Zhiping, M.D.
Johns Hopkins University
Principal Investigator: Zhiping Li, M.D. Johns Hopkins University
More Information

Responsible Party: Li, Zhiping, M.D.
ClinicalTrials.gov Identifier: NCT01688024     History of Changes
Other Study ID Numbers: NA_00052685
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Li, Zhiping, M.D.:
mitomycin C

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors