Minocycline in Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis Clinical Trial

Official title:

Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630942
• Other study ID #: 1559-02
• Status: Completed
• Phase: Phase 1
• First received: February 27, 2008
• Last updated: December 3, 2010
• Start date: February 2003
• Est. completion date: May 2007

Study information

• Verified date: December 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and estimate the efficacy at the maximally tolerated dose, 100 mg BID, in 30 patients with PSC.		1 year	Yes