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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Sclerosing Cholangitis | Drug: Minocycline | Phase 1 |
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 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Keith D. Lindor, M.D. | Mayo Clinic |
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 |
PSC |
Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases |
Digestive System Diseases Minocycline Anti-Bacterial Agents Anti-Infective Agents |