The purpose of the study is to see how safe and effective minocycline is in the treatment of
Primary Sclerosing Cholangitis (PSC).
Inclusion Criteria:
- Both genders
- Females of childbearing age must have negative pregnancy test within 48 hours of
participation and agreement to practice contraception for the duration of the study.
- Age 18 years old and < than 75 years old.
- History of chronic cholestatic disease of at least 6 months duration.
- Serum alkaline phosphatase level at least 1. 5 times the upper limit of normal.
- Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction,
beading, or narrowing consistent with PSC.
- Liver biopsy consistent with the diagnosis of PSC.
- Patient's informed consent for study participation.
Exclusion Criteria:
- Treatment with tetracyclines, ursodeoxycholic acid, corticosteroids, colchicine,
methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline,
perfenidone, nicotine, tacrolimus, silymarin, vitamin E or prednisone in the preceding
three months.
- Findings highly suggestive of hepatobiliary disease of other etiology complicating
PSC.
- Anticipated need for liver transplantation in one year determined by the Mayo model
with an estimate of <75% one year survival without transplantation.
- Recurrent variceal bleeding, presence of ascites, or encephalopathy.
- Active drug or alcohol use.
- Pregnancy.
- Breast-feeding.
- Serum creatinine over 1. 5 mg/dl.
- Prior history of allergic reactions to antibiotics belonging to the tetracycline
family.
- Any condition that, in the opinion of the investigator, would interfere with the
patient's ability to complete the study safely or successfully.
- Patients with active inflammatory bowel disease (IBD) requiring specific treatment in
the preceding three months, except for maintenance therapy with 5-ASA compounds, or
those individuals who have been involved in a trial evaluating any experimental drug
for the treatment of IBD in the preceding three months.
- Recurrent ascending cholangitis requiring hospitalization in the past year.
