Clinical trial NCT06174402: Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis
Official title: Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Primary Biliary Cholangitis
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

  1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
  2. Positive Anti-mitochondrial antibody (AMA) titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
  3. Documented liver biopsy result consistent with PBC.
* Incomplete response to UDCA defined by 1 x ULN\< 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, total bilirubin（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

Primary outcomes:
measure: Percentage of patients with biochemical response
timeFrame: 48 weeks
Secondary outcomes:
measure: Percentage of patients having biochemical response
timeFrame: 4, 12, 24 and 36weeks
measure: Assessment of the pruritus
timeFrame: 4, 12, 24, 36, and 48 weeks
measure: Assessment of the fatigue
timeFrame: 4, 12, 24, 36, and 48 weeks
measure: Percentage of patients having biological or clinical adverse events
timeFrame: 4, 12, 24, 36, and 48 weeks
measure: Survival without transplantation and hepatic impairment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The second hospital of Lanzhou University
state: Gansu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Second Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Yan'an
country: China
facility: Yan'an University Affiliated Hospital
state: Shanxxi
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: