Back to resultsMinocycline in Primary Sclerosing Cholangitis (PSC)
Primary Purpose
Primary Sclerosing Cholangitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Sponsored by
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring PSC
Eligibility 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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm, active treatment
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the safety and estimate the efficacy at the maximally tolerated dose, 100 mg BID, in 30 patients with PSC.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00630942
Brief Title
Minocycline in Primary Sclerosing Cholangitis (PSC)
Official Title
Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis
Keywords
PSC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm, active treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
Minocycline 100 mg capsules twice a day before breakfast and before dinner.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith D. Lindor, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Minocycline in Primary Sclerosing Cholangitis (PSC)
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