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

NCT02965911 | Withdrawn Phase 1 DMC

• 1 other identifier: BJ302-FGRXGB-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cirrhosis

Keywords

UDCA, Fenofibrate

Outcome Measures

Primary Outcomes (1)

• Serum Level of Alkaline Phosphatase(ALP) value

  To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

  12 months

Secondary Outcomes (3)

• Total bilirubin(TBIL) value

  12 months

• Aspartate aminotransferase(AST) value

  12 months

• Serum Level of Gamma-glutamyl transpeptidase (GGT) value

  12 months

Study Arms (2)

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.

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,

Drug: Fenofibrate; Drug: UDCA

Interventions

Fenofibrate DRUG

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.

Also known as: Antara, Fenoglide, Fibricor, Lipofen, Lofibra

Fenofibrate Combined with UDCA Treatment

UDCA DRUG

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.

Also known as: Ursa，Urso, Urso Forte, Ursocol, Ursofalk,

Fenofibrate Combined with UDCA Treatment; UDCA Standard treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ,signed informed consent after careful review of information and study details.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

Beijing 302 hospital

Beijing, 100039, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Fenofibrate; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Zhengsheng Zou, Dr.

  Beijing 302 Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: January 1, 2016
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)