|
Main
|
|
Note: This record shows only the 20 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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01085760 |
|
Date of registration:
|
10/03/2010 |
|
Primary sponsor: |
|
|
Public title:
|
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
PSC |
|
Scientific title:
|
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis |
|
Date of first enrolment:
|
February 2010 |
|
Target sample size:
|
35 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01085760 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Jayant A Talwalkar, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosis of PSC established by alkaline phosphatase >1.5 times and/or two fold
elevation of liver transaminases (AST and/or ALT) for at least 6 months duration.
- Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction,
beading, or narrowing consistent with PSC.
- Both genders.
- Age = 18 years old and < than 75 years old.
- Patient's informed consent for study participation.
Exclusion Criteria:
- Treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid,
corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil,
budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding
three months.
- Active drug or alcohol use.
- Prior history of allergic reactions to the antibiotics which will be used in the
study.
- Any condition that, in the opinion of the investigator, would interfere with the
patients' ability to complete the study safely or successfully.
- Evidence of decompensated liver disease such as recurrent variceal bleeding,
refractory ascites or spontaneous hepatic encephalopathy.
- Anticipated need for transplantation in one year (Mayo survival model <80% one-year
survival without transplant).
- Findings highly suggestive of liver disease of other etiology such as chronic
alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis,
Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary
biliary cirrhosis or secondary sclerosing cholangitis.
- Pregnancy or current lactation. Subjects becoming pregnant during the study will be
withdrawn.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Primary Sclerosing Cholangitis
|
|
Intervention(s)
|
|
Drug: Metronidazole
|
|
Drug: Vancomycin
|
|
Primary Outcome(s)
|
|
The primary endpoint will be the change in alkaline phosphatase following 12 weeks of treatment with each antibiotic, compared to the baseline value.
[Time Frame: 12 weeks]
|
|
Secondary Outcome(s)
|
|
Frequency of adverse events, comparison of change in alkaline phosphatase, AST, total bilirubin and Mayo risk score after 12 weeks of therapy, & change in pruritus, VAS score and fatigue severity as quantified by the questionnaires compared to baseline.
[Time Frame: 12 weeks]
|
|
Secondary ID(s)
|
|
08-008247
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|