Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

September 6, 2016 updated by: Li, Zhiping, M.D.

Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tinsay A. Woreta, M.D., M.P.H.
  • Phone Number: 410-955-2635
  • Email: tworeta1@jhmi.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21288
        • Recruiting
        • Johns Hopkins Hospital
        • Principal Investigator:
          • Zhiping Li, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with Adverse Events
Time Frame: Two years
Two years
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li, Zhiping, M.D.

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Zhiping Li, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00052685

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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