Minocycline in Primary Sclerosing Cholangitis (PSC)

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to see how safe and effective minocycline is in the treatment of Primary Sclerosing Cholangitis (PSC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Minocycline

Criteria

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, pirfenidone, 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.