Minocycline in Primary Sclerosing Cholangitis (PSC)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00630942
• Date of registration: 27/02/2008
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Minocycline in Primary Sclerosing Cholangitis (PSC)
• Scientific title: Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)
• Date of first enrolment: February 2003
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00630942
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Keith D. Lindor, M.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Intervention(s)

Drug: Minocycline

Primary Outcome(s)

To evaluate the safety and estimate the efficacy at the maximally tolerated dose, 100 mg BID, in 30 patients with PSC. [Time Frame: 1 year]

Secondary ID(s)

1559-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors