Recruiting NCT05749822
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fenofibrate 200mg, Placebo, UDCA.
- Who it may be relevant to
- Registry conditions: Primary Biliary Cholangitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid
Overview
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).
Detailed description
This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months.
Interventions
- Drug Fenofibrate 200mg
Fenofibrate 200mg/day - Drug Placebo
1 tablet/ day - Drug UDCA
UDCA 13-15mg/kg/day
Primary outcome measures
- Percentage of patients with biochemical response [Time frame: 48 weeks]
Secondary outcome measures (7)
- Percentage of patients having biochemical response [Time frame: 4, 12, 24 and 36weeks]
- Assessment of the pruritus and fatigue [Time frame: 4, 12, 24, 36, and 48 weeks]
- Percentage of patients having biological or clinical adverse events [Time frame: 4, 12, 24, 36, and 48 weeks]
- Percentage of patients having biological or clinical adverse events [Time frame: 4, 12, 24, 36, and 48 weeks]
- Percentage of patients having biological or clinical adverse events [Time frame: 4, 12, 24, 36, and 48 weeks]
- Percentage of patients having biological or clinical adverse events [Time frame: 4, 12, 24, 36, and 48 weeks]
- Survival without transplantation and hepatic impairment [Time frame: 48 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- History or presence of other concomitant liver diseases.
- ALT or AST > 5×ULN, TBIL > 3×ULN.
- If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
- Allergic to fenofibrate or ursodeoxycholic acid.
- Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
- Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
- Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
- Creatinine >1.5×ULN and creatinine clearance <60 ml/min.
- Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
- Planned to receive an organ transplant or an organ transplant recipient.
- Needing Liver transplantation within 1 year according to the Mayo Rick score.
- Any other condition(s) that would compromise the safety of the subject or compromise
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 12 centers
- Peking Union Medical College Hospital — Beijing
- Sun Yat-sen Memorial Hospital — Guangzhou
- Henan Provincial People's Hospital — Zhengzhou
- Xiangya Hospital Central South University — Changsha
- Jiangsu Province Hospital — Nanjing
- The First Hospital of China Medical University — Shenyang
- Xijing Hospital — Xi'an
- Yan'an University Affiliated Hospital — Yan’an
- … and 4 more centers
Identifiers
NCT: NCT05749822 · KY20222293-C-1