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Minocycline in Primary Sclerosing Cholangitis (PSC)

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

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

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Minocycline Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)
Study Start Date : February 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm, active treatment Drug: Minocycline
Minocycline 100 mg capsules twice a day before breakfast and before dinner.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630942


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Keith D. Lindor, M.D. Mayo Clinic
More Information
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Responsible Party: Dr. Keith D. Lindor, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00630942    
Other Study ID Numbers: 1559-02
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010
Keywords provided by Mayo Clinic:
PSC
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
 Digestive System Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents