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Minocycline in Primary Sclerosing Cholangitis (PSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00630942
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE February 27, 2008
First Posted Date  ICMJE March 7, 2008
Last Update Posted Date December 7, 2010
Study Start Date  ICMJE February 2003
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minocycline in Primary Sclerosing Cholangitis (PSC)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE Drug: Minocycline
Minocycline 100 mg capsules twice a day before breakfast and before dinner.
Study Arms  ICMJE Experimental: Single Arm, active treatment
Intervention: Drug: Minocycline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2008)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630942
Other Study ID Numbers  ICMJE 1559-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Keith D. Lindor, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith D. Lindor, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP