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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00490620 |
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Date of registration:
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21/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Combivir for Patients With Primary Biliary Cirrhosis
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Scientific title:
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Randomized Controlled Pilot Study of Combivir for Patients With Primary Biliary Cirrhosis |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00490620 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Canada
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United Kingdom
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United States
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Contacts
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Name:
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Catherine Vincent, MD FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Université de Montréal |
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Name:
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James Neuberger, MD FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Birmingham |
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Name:
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Keith Lindor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic Foundation |
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Name:
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Andrew L Mason, MBBS MRCPI |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Name:
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Bruce Bacon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Louis University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients 18 years old of either sex will be recruited for this study.
- Persistently elevated alkaline phosphatase or serum aminotransferases of at least 1.5
times normal after a minimum of 6 months UDCA therapy.
- Positive serum AMA (titer > 1:20).
- Liver biopsy histology compatible with PBC obtained at any time prior to study.
- Maintained on UDCA at a dose of 13-15 mg/kg for 6 or more months.
- Patients must read and sign informed consent form.
Exclusion Criteria:
- Patients treated with immunosuppressive or anti-inflammatory agents such as
colchicine, methotrexate, D-penicillamine, cyclosporine, tacrolimus, mycophenolate
mofetil, corticosteroid therapy will be excluded but may enter the study after a 3
month period off immunosuppressive and anti-inflammatory therapy.
- Advanced liver disease: Childs Pugh class B or C cirrhosis, recurrent variceal
hemorrhage, spontaneous encephalopathy, diuretic resistant ascites, need for liver
transplantation within the year.
- Patients with a secondary hepatic diagnosis such as viral hepatitis, drug induced
liver injury, extrahepatic biliary obstruction, primary sclerosing cholangitis,
metabolic liver diseases or alcoholic liver disease.
- Regular use of more than 30 g of alcohol per day in the last year.
- Patients with a predicted survival of less than 3 years from malignant or other
potentially life threatening disease.
- Creatinine clearance less than < 70 mL/min using the Cockcroft Gault equation:
- Clinically apparent pancreatitis.
- Serum amylase > 3 x upper limit of normal (patients with sicca syndrome and salivary
gland disease may have elevated amylase levels)
- Pregnancy or breast-feeding a child.
- Sexually active patients of child bearing age and not using effective contraception.
- Allergic reaction to Combivir like drugs
- Clinical evidence of myositis
- Weight of < 50 Kg
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cirrhosis
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Intervention(s)
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Drug: Combination antiviral therapy
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Drug: Placebo
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Primary Outcome(s)
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The percentage of patients with either (i) normalized alkaline phosphatase, (ii) normalized AST and ALT or (iii) normal alkaline phosphatase, AST and ALT will be recorded.
[Time Frame: During the 6 months of therapy]
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Secondary Outcome(s)
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50% improvement towards baseline for alkaline phosphatase, AST and ALT, changes in symptoms using an objective graded clinical parameter scale, serum AMA titers, quantitative immunoglobulins and virologic parameters.
[Time Frame: During the 6 months of therapy]
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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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