Primary Sclerosing Cholangitis
Conditions
Keywords
mitomycin C
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).
Interventions
DRUGMitomycin C
DRUGNormal saline
Sponsors
Johns Hopkins University
Li, Zhiping, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis | Two years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients with Adverse Events | Two years |
| Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications | Two years |
Countries
United States
Contacts
Primary ContactPo-Hung Chen, M.D.
Backup ContactTinsay A. Woreta, M.D., M.P.H.
Outcome results
None listed