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Minocycline in Primary Sclerosing Cholangitis (PSC)

NCT ID: NCT00630942

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Primary Sclerosing Cholangitis

Keywords

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PSC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Single Arm, active treatment

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

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

Interventions

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Minocycline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Keith D. Lindor, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1559-02

Identifier Type: -

Identifier Source: org_study_id