Clinical Trial: Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Li, Zhiping, M.D.

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Li, Zhiping, M.D.

Dates:
Date Received: September 10, 2012
Date Started: September 2012
Date Completion: September 2019
Last Updated: September 6, 2016
Last Verified: September 2016