Minocycline in Primary Sclerosing Cholangitis (PSC)

• ClinicalTrials.gov Identifier: NCT00630942
• Recruitment Status: Completed
• First Posted: March 7, 2008
• Last Update Posted: December 7, 2010
• Sponsor: Mayo Clinic
• Information provided by: Mayo Clinic

Tracking Information

• First Submitted Date: February 27, 2008
• First Posted Date: March 7, 2008
• Last Update Posted Date: December 7, 2010
• Study Start Date: February 2003
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 27, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Minocycline in Primary Sclerosing Cholangitis (PSC)
• Official Title: Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)
• Brief Summary: The purpose of the study is to see how safe and effective minocycline is in the treatment of Primary Sclerosing Cholangitis (PSC).
• Detailed Description: The purpose of the study is to determine the safety profile of minocycline in patients with PSC and to compare the effects of minocycline on the baseline values of the following parameters: symptoms of pruritus and fatigue, liver biochemistries, Mayo Risk Score, the development of clinical progression and complications of liver disease.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Primary Purpose: Treatment
• Condition: Primary Sclerosing Cholangitis

Intervention

Drug: Minocycline

Minocycline 100 mg capsules twice a day before breakfast and before dinner.

Study Arms

Experimental: Single Arm, active treatment

Intervention: Drug: Minocycline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 27, 2008): 16
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2007
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00630942
• Other Study ID Numbers: 1559-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Keith D. Lindor, M.D., Mayo Clinic
• Study Sponsor: Mayo Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Keith D. Lindor, M.D.; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: December 2010