Trial Outcomes & Findings for Use of Fenofibrate for Primary Biliary Cirrhosis (NCT NCT00575042)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

1 year

Results posted on

2018-03-08

Patients were recruited from the liver clinics at University of Florida and Mayo Clinic Rochester.

Participant milestones
Measure	Fenofibrate 160 mg Per Day Fenofibrate (Insoluble Drug Deliver-Micro Particle Fenofibrate (IDD-P)) 160 mg per day
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Fenofibrate 160 mg Per Day Fenofibrate (Insoluble Drug Deliver-Micro Particle Fenofibrate (IDD-P)) 160 mg per day
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	1

Use of Fenofibrate for Primary Biliary Cirrhosis

Baseline characteristics by cohort
Measure	Patients Treated With Fenofibrate n=20 Participants Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

Timeframe: 1 year

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

Outcome measures
Measure	Patients Before Treatment With Fenofibrate n=20 Participants Patients with previous incomplete response to UDCA	Patients Treated With Fenofibrate n=17 Participants Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
Serum Level of Alkaline Phosphatase	351 U/L Interval 214.0 to 779.0	175 U/L Interval 60.0 to 384.0

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	Patients Treated With Fenofibrate n=20 participants at risk Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
Gastrointestinal disorders heartburn	5.0% 1/20 • Number of events 1 • Adverse events were collected for 15 months

Other adverse events
Measure	Patients Treated With Fenofibrate n=20 participants at risk Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
Gastrointestinal disorders heartburn	20.0% 4/20 • Number of events 4 • Adverse events were collected for 15 months
Gastrointestinal disorders nausea	10.0% 2/20 • Number of events 2 • Adverse events were collected for 15 months
Hepatobiliary disorders transient elevation of transaminases	10.0% 2/20 • Number of events 2 • Adverse events were collected for 15 months
Gastrointestinal disorders diarrhea	10.0% 2/20 • Number of events 2 • Adverse events were collected for 15 months

University of Miami

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