Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01688024
• Other study ID #: NA_00052685
• Status: Recruiting
• Phase: Phase 2
• First received: September 10, 2012
• Last updated: September 6, 2016
• Start date: September 2012
• Est. completion date: September 2019

Study information

• Verified date: September 2016
• Source: Li, Zhiping, M.D.
• Contact: Po-Hung Chen, M.D.
• Phone: 410-502-6072
• Email: pchen37[@]jhmi.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

Drug:
• Mitomycin C

• Normal saline

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Li, Zhiping, M.D.	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis		Two years	No
Secondary	Number of Patients with Adverse Events		Two years	Yes
Secondary	Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications		Two years	No