Minocycline in Primary Sclerosing Cholangitis (PSC)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00630942
First received: February 27, 2008
Last updated: December 3, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Primary Sclerosing Cholangitis
Drug: Minocycline
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: February 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm, active treatment Drug: Minocycline
Minocycline 100 mg capsules twice a day before breakfast and before dinner.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630942

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Keith D. Lindor, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Dr. Keith D. Lindor, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00630942     History of Changes
Other Study ID Numbers: 1559-02
Study First Received: February 27, 2008
Last Updated: December 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
PSC

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014