Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2012 |
| End Date: | September 2019 |
| Contact: | Po-Hung Chen, M.D. |
| Email: | pchen37@jhmi.edu |
| Phone: | 410-502-6072 |
Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
The purpose of this study is to determine the effectiveness and safety of mitomycin C in the
treatment of primary sclerosing cholangitis (PSC).
treatment of primary sclerosing cholangitis (PSC).
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
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