NCT00575042

Brief Summary

This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 9, 2012

Completed
Last Updated

March 8, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

December 13, 2007

Results QC Date

December 2, 2011

Last Update Submit

February 7, 2018

Conditions

Primary Biliary Cirrhosis

Keywords

PBCPrimary Biliary CirrhosisFenofibrateTriglide

Outcome Measures

Primary Outcomes (1)

  • Serum Level of Alkaline Phosphatase

    We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.

    1 year

Study Arms (1)

Patients treated with Fenofibrate

EXPERIMENTAL

Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg table per day for 1 year

Drug: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)

Interventions

Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)DRUG

160 mg per day for 1 year

Also known as: Triglide-Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)
Patients treated with Fenofibrate

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)
  • Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
  • Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal on two separate measurements
  • Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period
  • Signed informed consent after careful review of the information and study details by one of the investigators

You may not qualify if:

  • Hypersensitivity to fenofibrate
  • Prisoners and institutionalized subjects
  • Pregnant or nursing women
  • Anticipated need for liver transplantation in one year (estimated one year survival \< 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.
  • Recipients of liver transplantation
  • Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
  • Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma
  • Acute or chronic renal failure
  • Known history of cholecystitis with intact gallbladder
  • Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Levy C, Peter J, Keach J, Petz J, Lindor KD, Cabrera R, et al. Fenofibrate improves liver biochemistries in primary biliary cirrhosis. Hepatology. 2009;50(4 (suppl)):995A.

    BACKGROUND

  • Levy C, Peter JA, Nelson DR, Keach J, Petz J, Cabrera R, Clark V, Firpi RJ, Morelli G, Soldevila-Pico C, Lindor K. Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. Aliment Pharmacol Ther. 2011 Jan;33(2):235-42. doi: 10.1111/j.1365-2036.2010.04512.x. Epub 2010 Nov 17.

    PMID: 21083674RESULT

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

A major limitation is the uncontrolled nature of this study.

Results Point of Contact

Title
Dr. Cynthia Levy
Organization
University of Miami
clevy@med.miami.edu
305-243-2330

Study Officials

  • Cynthia Levy, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 17, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

March 8, 2018

Results First Posted

January 9, 2012

Record last verified: 2018-02

Locations

US(2)