Primary Biliary CirrhosisPhase 2NCT01141296
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
A Phase 2 study testing fenofibrate in people with Primary Biliary Cirrhosis, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 and ≤ 75 years old
- Established diagnosis of PBC and positive AMA
- Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
- Incomplete response to UDCA defined as serum ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA
- Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period
- Signed informed consent after careful review of information and study details
Who cannot join
- Hypersensitivity to fenofibrate
- Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
- Prisoners and institutionalized subjects, pregnant or nursing women
- Anticipated need for liver transplantation within one year (estimated 1-year survival <80% as predicted by the Mayo risk score).
- Recipients of liver transplantation
- Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
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- Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
- Acute or chronic renal failure, defined as GFR < 60 ml/min
- Known history of cholecystitis with intact gallbladder
- History of, or known high risk for, venous thromboembolism
- Current use of warfarin or statins
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida, 33136
Mayo Clinic Rochester
Rochester, Minnesota, 55902
About this study
Official title: Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- fenofibrate, placebo
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrateDrug
fenofibrate 200 mg PO daily for 1 year
placeboDrug
Placebo pill identical to active drug will be given PO once a day for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Active comparator | Not described Receives: Drug: fenofibrate |
| sugar pill | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum alkaline phosphatase level
Measured: one year
Secondary outcomes (5)
Symptoms - quality of life
Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study
Measured: one year
symptoms - pruritus
Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study
Measured: one year
symptom -fatigue
fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study
Measured: one year
interleukin 1
IL-1 will be measured from stored serum collected at entry and end of study. This will be measured by Beadlyte Human Multicytokine Detection system.
Measured: one year
interleukin 6
IL-6 will be measured from stored serum collected at entry and end of study. This will be measured by Beadlyte Human Multicytokine Detection system.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startApr 2011
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Cynthia Levy, University of Miami
- Investigators
- Cynthia Levy, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141296
- Sponsor's protocol ID
- Feno-01
- Status last verified
- Mar 2014
- First submitted
- 8 Jun 2010
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
- ClinicalTrials.gov ID
- NCT01141296
- Acronym / sponsor ID
- Feno-01
- Conditions
- Primary Biliary Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Apr 2011
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Active comparator | Drug: fenofibrate |
| sugar pill | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 21 and ≤ 75 years old
- Established diagnosis of PBC and positive AMA
- Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
- Incomplete response to UDCA defined as serum ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA
- Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period
Key exclusion criteria (11 listed)
- Hypersensitivity to fenofibrate
- Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
- Prisoners and institutionalized subjects, pregnant or nursing women
- Anticipated need for liver transplantation within one year (estimated 1-year survival <80% as predicted by the Mayo risk score).
- Recipients of liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenofibratefenofibrate 200 mg PO daily for 1 year | Drug | Fenofibrate |
| placeboPlacebo pill identical to active drug will be given PO once a day for 1 year | Drug | sugar pill |
Primary outcome
Serum alkaline phosphatase level
Time frame: one year
5 secondary outcomes
Symptoms - quality of life
Time frame: one year
symptoms - pruritus
Time frame: one year
symptom -fatigue
Time frame: one year
interleukin 1
Time frame: one year
interleukin 6
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Levy, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fenofibrate in people with Primary Biliary Cirrhosis, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum alkaline phosphatase level (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.