Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Must have provided written informed consent

• Age 18-75 years;

• BMI 17-28 kg/m2

• Male or female with a diagnosis of PBC, by at least two of the following criteria:

‣ History of AP above ULN for at least six months;

⁃ Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;

⁃ Documented liver biopsy result consistent with PBC.

• Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor

‣ The histology was consistent with the diagnosis of liver cirrhosi;

⁃ Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;

⁃ Ultrasound or CT and other imaging examinations indicate the characteristics of liver cirrhosis or portal hypertension, such as splenomegaly, portal vein ≥ 1.3 cm, or liver stiffness measured by transient elastography\>16.9 kPa;

⁃ Abnormal laboratory inspection indicators (2 out of 4): 1) PLT \< 100 × 109/L, and no other reason can be explained; 2) Serum albumin\<35 g/L, excluding malnutrition or kidney disease and other causes; 3) INR \> 1.3 or PT prolongation (stop thrombolytic or anticoagulant drugs for more than 7 days); 4) AST/PLT (APRI)\>2)

• Incomplete response to UDCA defined by ALP \> 1.67 x ULN

• Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Xiangya Hospital Central South University
RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Sun Yat-sen Memorial Hospital
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Jiangsu Province Hospital
RECRUITING
Nanjing
The First Hospital of China Medical University
RECRUITING
Shenyang
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Tianjin Third Central Hospital
RECRUITING
Tianjin
Xijing Hospital
RECRUITING
Xi'an
Yan'an University Affiliated Hospital
RECRUITING
Yan’an
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Yulong Shang
shangyl870222@163.com
+86-29-84771539
Backup
Ying Han
hanying1@fmmu.edu.cn
+86-29-84771539
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 104
Treatments
Placebo_comparator: Placebo-UDCA
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
Experimental: Fenofibrate-UDCA
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
Sponsors
Leads: Xijing Hospital of Digestive Diseases

This content was sourced from clinicaltrials.gov