Recruiting
Phase 2

Mitomycin C

Sponsor:

Li, Zhiping, M.D.

Code:

NCT01688024

Conditions

Primary Sclerosing Cholangitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mitomycin C

Normal saline

Study Details

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).

Conditions

Primary Sclerosing Cholangitis

Study ID

NCT01688024

Start date

Sep, 2012

Status verified date

Sep, 2016

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Mitomycin C

Normal saline

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Po-Hung Chen, M.D.

410-502-6072pchen37@jhmi.edu

Tinsay A. Woreta, M.D., M.P.H.

410-955-2635tworeta1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21288

Principal Investigator:

Zhiping Li, M.D.

More Information

Sponsor

Li, Zhiping, M.D.

Last update posted

Sep 7, 2016

Last verified

Sep, 2016

Keywords

  • mitomycin C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Li, Zhiping, M.D. on 2016-09-07.