Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
1 other identifier
interventional
130
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 10, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedSeptember 7, 2016
September 1, 2016
5 years
September 10, 2012
September 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
Two years
Secondary Outcomes (2)
Number of Patients with Adverse Events
Two years
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
Two years
Study Arms (2)
Mitomycin C
EXPERIMENTALUp to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given.
Normal saline
PLACEBO COMPARATORGiven during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed.
Interventions
Eligibility Criteria
You may qualify if:
- Ages 18 or older
- Previously established diagnosis of primary sclerosing cholangitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Li, Zhiping, M.D.lead
- Johns Hopkins Universitycollaborator
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21288, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhiping Li, M.D.
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2012
First Posted
September 19, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2017
Study Completion
September 1, 2019
Last Updated
September 7, 2016
Record last verified: 2016-09