Study of Combivir for Patients With Primary Biliary Cirrhosis

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Primary Biliary Cirrhosis

In brief

This is a proof of principal study to determine whether combination anti-viral therapy with Combivir impacts on hepatic biochemistry in patients with primary biliary cirrhosis

Key facts

Study ID

NCT00490620

Run by

University of Alberta

People needed

59

Starts

2004-01-01

Expected to finish

2007-04-01

Last updated by the study team

2007-11-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• St Louis University — St Louis, Missouri, United States
• University of Alberta — Edmonton, Alberta, Canada
• University of Montreal — Montreal, Quebec, Canada
• University of Birmingham — Birmingham, England, United Kingdom

Full record on ClinicalTrials.gov

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