Suspended
Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
What is being tested
Mitomycin C
+ Normal saline
Drug
Who is being recruted
Bile Duct Diseases+2
+ Biliary Tract Diseases
+ Cholangitis
Over 18 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: September 2012
Summary
Principal SponsorLi, Zhiping, M.D.
Study ContactPo-Hung Chen, M.D.More contacts
Last updated: September 7, 2016Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).
Principal SponsorLi, Zhiping, M.D.
Study ContactPo-Hung Chen, M.D.More contacts
Last updated: September 7, 2016Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
130 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bile Duct DiseasesBiliary Tract DiseasesCholangitisDigestive System DiseasesCholangitis, Sclerosing
Criteria
2 inclusion criteria required to participate
Ages 18 or older
Previously established diagnosis of primary sclerosing cholangitis
11 exclusion criteria prevent from participating
American Society of Anesthesiologists class 4 or greater
Dyspnea with minimal exertion (or supplemental oxygen dependence)
History of bone marrow disease
Inability to provide informed consent
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
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.
Group II
PlaceboGiven during each standard of care endoscopic retrograde cholangiography.
No more than five normal saline applications per every twelve months will be performed.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center