Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Li, Zhiping, M.D.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Li, Zhiping, M.D.
ClinicalTrials.gov Identifier:
NCT01688024
First received: September 10, 2012
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Primary Sclerosing Cholangitis
Drug: Mitomycin C
Drug: Normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis

Resource links provided by NLM:


Further study details as provided by Li, Zhiping, M.D.:

Primary Outcome Measures:
  • Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients with Adverse Events [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: September 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688024

Contacts
Contact: Po-Hung Chen, M.D. 410-614-0950 pchen37@jhmi.edu
Contact: Tinsay A. Woreta, M.D., M.P.H. 410-955-2635 tworeta1@jhmi.edu

Locations
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
Investigators
Principal Investigator: Zhiping Li, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Li, Zhiping, M.D.
ClinicalTrials.gov Identifier: NCT01688024     History of Changes
Other Study ID Numbers: NA_00052685
Study First Received: September 10, 2012
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 31, 2014