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