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

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ClinicalTrials.gov Identifier: NCT02965911
Recruitment Status : Unknown
Verified June 2016 by Beijing 302 Hospital.
Recruitment status was:  Recruiting
First Posted : November 17, 2016
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Beijing 302 Hospital

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.

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Fenofibrate Drug: UDCA Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Active Comparator: UDCA Standard treatment
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.
Drug: UDCA
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.
Other Name: Ursa,Urso, Urso Forte, Ursocol, Ursofalk,

Experimental: Fenofibrate Combined with UDCA Treatment
All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month,
Drug: Fenofibrate
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.
Other Name: Antara, Fenoglide, Fibricor, Lipofen, Lofibra

Drug: UDCA
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.
Other Name: Ursa,Urso, Urso Forte, Ursocol, Ursofalk,




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total bilirubin(TBIL) value [ Time Frame: 12 months ]
    To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

  2. Aspartate aminotransferase(AST) value [ Time Frame: 12 months ]
    To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

  3. Serum Level of Gamma-glutamyl transpeptidase (GGT) value [ Time Frame: 12 months ]
    To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965911


Contacts
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Contact: Zhengsheng Zou, Dr. +861066933424 zszou302@163.com
Contact: Ying Sun, Dr. +861066933424 sunying_302@yahoo.com

Locations
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China
Beijing 302 hospital Recruiting
Beijing, China, 100039
Contact: Zhengsheng Zou, Dr.         
Principal Investigator: Zhengsheng Zou, Dr.         
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
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Study Director: Zhengsheng Zou, Dr. Beijing 302 Hospital
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Responsible Party: Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT02965911    
Other Study ID Numbers: BJ302-FGRXGB-002
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Beijing 302 Hospital:
UDCA, Fenofibrate
Additional relevant MeSH terms:
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Liver Cirrhosis, Biliary
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Liver Cirrhosis
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents