Primary Biliary CirrhosisPhase 3NCT02823353
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
A Phase 3 study testing Fenofibrate and UDCA in people with Primary Biliary Cirrhosis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- Fenofibrate and UDCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2016to Jun 2022
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST/ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.
Who cannot join
- Pregnancy or desire of pregnancy.
- Breast-feeding.
- 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
- History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
- History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn).
- Hepatotoxic drugs use before recruiting.
- Fenofibrate anaphylaxis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- Fenofibrate, UDCA
- Keywords
- PBC, UDCA, Fenofibrate
- 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 200mg/day
UDCADrug
UDCA 13-15mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate + UDCA | Experimental | Fenofibrate (200 mg/day) in combination with ursodeoxycholic acid (13-15 mg/kg/day) Receives: Drug: Fenofibrate; Drug: UDCA |
| Monotherapy | Active comparator | UDCA 13-15mg/kg/day Receives: Drug: UDCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with complete biochemical response
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
Measured: Week 48
Secondary outcomes (6)
Change in liver biopsy examinations according to conventional Ludwig system.
Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status. The Ludwig histological classification schemes will be used, which categorised the disease into four stages.
Measured: Week 48
GLOBE risk scores at week 48.
The prognostic scores will be calculated at end of the study by GLOBE scoring system (proposed by Global PBC Study Group), which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of UDCA therapy and age at baseline.
Measured: Week 48
Change in liver stiffness status measured by magnetic resonance elastography.
The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.
Measured: Week 48
Change in serum levels of ALP compared to the baseline.
Absolute change in serum levels of ALP compared to the baseline.
Measured: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of bilirubin compared to the baseline.
Absolute change in serum levels of bilirubin compared to the baseline.
Measured: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of transaminase compared to the baseline.
Absolute change in serum levels of transaminase compared to the baseline.
Measured: Weeks 0, 4, 8, 12, 24, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start8 Apr 2016
- Primary completion6 May 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Ying, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823353
- Sponsor's protocol ID
- KY20151230-4
- Status last verified
- Sep 2022
- First submitted
- 28 Jan 2016
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu Y, Guo G, Zheng L, Sun R, Wang X, Deng J, Jia G, Yang C, Cui L, Guo C, Shang Y, Han Y. Effectiveness of Fenofibrate in Treatment-Naive Patients With Primary Biliary Cholangitis: A Randomized Clinical Trial. Am J Gastroenterol. 2023 Nov 1;118(11):1973-1979. doi: 10.14309/ajg.0000000000002238. Epub 2023 Mar 9.
PubMed 36892506
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study
- ClinicalTrials.gov ID
- NCT02823353
- Acronym / sponsor ID
- KY20151230-4
- Conditions
- Primary Biliary Cirrhosis
- Keywords
- PBC, UDCA, Fenofibrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 6 Jul 2016 (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.
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate + UDCA | Experimental | Drug: Fenofibrate, Drug: UDCAFenofibrate (200 mg/day) in combination with ursodeoxycholic acid (13-15 mg/kg/day) |
| Monotherapy | Active comparator | Drug: UDCAUDCA 13-15mg/kg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST/ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.
Key exclusion criteria (7 listed)
- Pregnancy or desire of pregnancy.
- Breast-feeding.
- 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
- History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
- History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn).
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 200mg/day | Drug | Fenofibrate + UDCA |
| UDCAUDCA 13-15mg/kg/day | Drug | Fenofibrate + UDCA, Monotherapy |
Primary outcome
Rate of patients with complete biochemical response
Time frame: Week 48
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
6 secondary outcomes
Change in liver biopsy examinations according to conventional Ludwig system.
Time frame: Week 48
GLOBE risk scores at week 48.
Time frame: Week 48
Change in liver stiffness status measured by magnetic resonance elastography.
Time frame: Week 48
Change in serum levels of ALP compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of bilirubin compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of transaminase compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 36892506Liu Y, Guo G, Zheng L, Sun R, Wang X, Deng J, Jia G, Yang C, Cui L, Guo C, Shang Y, Han Y. Effectiveness of Fenofibrate in Treatment-Naive Patients With Primary Biliary Cholangitis: A Randomized Clinical Trial. Am J Gastroenterol. 2023 Nov 1;118(11):1973-1979. doi: 10.14309/ajg.0000000000002238. Epub 2023 Mar 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fenofibrate and UDCA in people with Primary Biliary Cirrhosis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of patients with complete biochemical response (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02823353, which also lists 1 linked publication.
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 8 Mar 2023.