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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

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring mitomycin C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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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