Minocycline in Primary Sclerosing Cholangitis (PSC)

NCT00630942 | Completed Phase 1

• 1 other identifier: 1559-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Sclerosing Cholangitis

Keywords

PSC

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and estimate the efficacy at the maximally tolerated dose, 100 mg BID, in 30 patients with PSC.

  1 year

Study Arms (1)

Single Arm, active treatment

EXPERIMENTAL

Drug: Minocycline

Interventions

Minocycline DRUG

Minocycline 100 mg capsules twice a day before breakfast and before dinner.

Single Arm, active treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Keith D. Lindor, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: December 7, 2010

Record last verified: 2010-12

Locations

US (1)