Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 September 2016 |
Main ID: |
NCT01688024 |
Date of registration:
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10/09/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
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Scientific title:
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Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis |
Date of first enrolment:
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September 2012 |
Target sample size:
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130 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT01688024 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Zhiping Li, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Name:
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Po-Hung Chen, M.D. |
Address:
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Telephone:
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410-502-6072 |
Email:
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pchen37@jhmi.edu |
Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Sclerosing Cholangitis
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Intervention(s)
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Drug: Normal saline
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Drug: Mitomycin C
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Primary Outcome(s)
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Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
[Time Frame: Two years]
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Secondary Outcome(s)
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Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
[Time Frame: Two years]
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Number of Patients with Adverse Events
[Time Frame: Two years]
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Secondary ID(s)
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NA_00052685
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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