Primary Biliary CirrhosisPhase 1/2NCT02965911
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
A Phase 1/2 study testing Fenofibrate and UDCA in people with Primary Biliary Cirrhosis, run by Beijing 302 Hospital at 1 site in China.
Trial summary
The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- Fenofibrate and UDCA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to 8 Sep 2021
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PBC Patient , previous treatment with UDCA 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response;
- Patients who showing an incomplete biochemical response to UDCA as defined by: ALP > 3ULN,AST> 2N ,total bilirubin >17 µmol/l after ≥ 12 months of UDCA at the dose of 13 - 15 mg/kg/day.
- 3,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.
- Decompensation PBC, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
- Anticipated need for liver transplantation within one year
- 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
- Known history of cholecystitis with intact gallbladder
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA
The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
Read the detailed description
Primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (UDCA) is the only drug approved for the treatment of PBC. Although UDCA can improve the clinical outcomes in patients with PBC, about 40% of PBC patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. Therefor there is a urgently needed for better therapies for these patients. The development of new treatments is therefore needed. The Fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that Fenofibrate is well tolerated and can improve biochemical response in PBC patients with incompleted response to UDCA. The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- Fenofibrate, UDCA
- Keywords
- 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
Also called Antara, Fenoglide, Fibricor, Lipofen, Lofibra
Fenofibrate is a drug of the fibrate class. it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein (HDL) levels and reducing triglyceride levels.
UDCADrug
Also called Ursa，Urso, Urso Forte, Ursocol, Ursofalk,
Ursodeoxycholic acid，the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria，it is the only FDA approved drug to treat PBC.
| Study group | Role | What they receive |
|---|---|---|
| UDCA Standard treatment | Active comparator | All subjects will reiceive UDCA at a dose of 13-15mg/kg/d by oral for 12 months, and UDCA will be maintained after 12 months. Receives: Drug: UDCA |
| Fenofibrate Combined with UDCA Treatment | Experimental | All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month, Receives: Drug: Fenofibrate; Drug: UDCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Level of Alkaline Phosphatase(ALP) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Measured: 12 months
Secondary outcomes (3)
Total bilirubin(TBIL) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Measured: 12 months
Aspartate aminotransferase(AST) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Measured: 12 months
Serum Level of Gamma-glutamyl transpeptidase (GGT) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJan 2016
- Primary completion8 Sep 2021 (estimated)
- Study completion8 Sep 2021
Why it stopped: No participants enrolled
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengsheng Zou, Dr., Study director, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965911
- Sponsor's protocol ID
- BJ302-FGRXGB-002
- Status last verified
- Sep 2021
- First submitted
- 15 Nov 2016
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA
- ClinicalTrials.gov ID
- NCT02965911
- Acronym / sponsor ID
- BJ302-FGRXGB-002
- Conditions
- Primary Biliary Cirrhosis
- Keywords
- UDCA, Fenofibrate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 8 Sep 2021 (estimated)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 17 Nov 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.
The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
Detailed description
Primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (UDCA) is the only drug approved for the treatment of PBC. Although UDCA can improve the clinical outcomes in patients with PBC, about 40% of PBC patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. Therefor there is a urgently needed for better therapies for these patients. The development of new treatments is therefore needed. The Fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that Fenofibrate is well tolerated and can improve biochemical response in PBC patients with incompleted response to UDCA. The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UDCA Standard treatment | Active comparator | Drug: UDCAAll subjects will reiceive UDCA at a dose of 13-15mg/kg/d by oral for 12 months, and UDCA will be maintained after 12 months. |
| Fenofibrate Combined with UDCA Treatment | Experimental | Drug: Fenofibrate, Drug: UDCAAll subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month, |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PBC Patient , previous treatment with UDCA 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response;
- Patients who showing an incomplete biochemical response to UDCA as defined by: ALP > 3ULN,AST> 2N ,total bilirubin >17 µmol/l after ≥ 12 months of UDCA at the dose of 13 - 15 mg/kg/day.
- 3,signed informed consent after careful review of information and study details.
Key exclusion criteria (8 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.
- Decompensation PBC, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
- Anticipated need for liver transplantation within one year
- 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
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 |
|---|---|---|
| FenofibrateAlso: Antara, Fenoglide, Fibricor, Lipofen, LofibraFenofibrate is a drug of the fibrate class. it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein (HDL) levels and reducing triglyceride levels. | Drug | Fenofibrate Combined with UDCA Treatment |
| UDCAAlso: Ursa，Urso, Urso Forte, Ursocol, Ursofalk,Ursodeoxycholic acid，the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria，it is the only FDA approved drug to treat PBC. | Drug | Fenofibrate Combined with UDCA Treatment, UDCA Standard treatment |
Primary outcome
Serum Level of Alkaline Phosphatase(ALP) value
Time frame: 12 months
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
3 secondary outcomes
Total bilirubin(TBIL) value
Time frame: 12 months
Aspartate aminotransferase(AST) value
Time frame: 12 months
Serum Level of Gamma-glutamyl transpeptidase (GGT) value
Time frame: 12 months
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 17 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Zhengsheng Zou, Dr. study director
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fenofibrate and UDCA in people with Primary Biliary Cirrhosis, run by Beijing 302 Hospital 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 3 inclusion and 8 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 17 Sep 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Level of Alkaline Phosphatase(ALP) value (time frame: 12 months). 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 17 Sep 2021.