search
Back to results

Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA

Primary Purpose

Primary Biliary Cirrhosis

Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fenofibrate
UDCA
Sponsored by
Beijing 302 Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring UDCA, Fenofibrate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. PBC Patient , previous treatment with UDCA 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response;
  2. 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.

Exclusion Criteria:

  1. Hypersensitivity to fenofibrate
  2. Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
  3. Decompensation PBC, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
  4. Anticipated need for liver transplantation within one year
  5. 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
  6. Acute or chronic renal failure
  7. Known history of cholecystitis with intact gallbladder
  8. Pregnant or nursing women

Sites / Locations

  • Beijing 302 hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

UDCA Standard treatment

Fenofibrate Combined with UDCA Treatment

Arm Description

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.

All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month,

Outcomes

Primary Outcome Measures

Serum Level of Alkaline Phosphatase(ALP) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

Secondary Outcome Measures

Total bilirubin(TBIL) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Aspartate aminotransferase(AST) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
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.

Full Information

First Posted
November 15, 2016
Last Updated
September 12, 2021
Sponsor
Beijing 302 Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02965911
Brief Title
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 8, 2021 (Anticipated)
Study Completion Date
September 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
UDCA, Fenofibrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UDCA Standard treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fenofibrate Combined with UDCA Treatment
Arm Type
Experimental
Arm Description
All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month,
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Other Intervention Name(s)
Antara, Fenoglide, Fibricor, Lipofen, Lofibra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
UDCA
Other Intervention Name(s)
Ursa，Urso, Urso Forte, Ursocol, Ursofalk,
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum Level of Alkaline Phosphatase(ALP) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total bilirubin(TBIL) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months
Title
Aspartate aminotransferase(AST) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months
Title
Serum Level of Gamma-glutamyl transpeptidase (GGT) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengsheng Zou, Dr.
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing 302 hospital
City
Beijing
ZIP/Postal Code
100039
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA

We'll reach out to this number within 24 hrs