Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
Primary Purpose
Primary Sclerosing Cholangitis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mitomycin C
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring mitomycin C
Eligibility 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
Sites / Locations
- Johns Hopkins HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mitomycin C
Normal saline
Arm 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.
Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed.
Outcomes
Primary Outcome Measures
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
Secondary Outcome Measures
Number of Patients with Adverse Events
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
Full Information
NCT ID
NCT01688024
First Posted
September 10, 2012
Last Updated
September 6, 2016
Sponsor
Li, Zhiping, M.D.
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01688024
Brief Title
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
Official Title
Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Li, Zhiping, M.D.
Collaborators
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis
Keywords
mitomycin C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mitomycin C
Arm Type
Experimental
Arm 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.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Intervention Type
Drug
Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Number of Patients with Adverse Events
Time Frame
Two years
Title
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Hung Chen, M.D.
Phone
410-502-6072
Email
pchen37@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tinsay A. Woreta, M.D., M.P.H.
Phone
410-955-2635
Email
tworeta1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiping Li, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21288
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiping Li, M.D.
12. IPD Sharing Statement
Learn more about this trial
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
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