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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06174402
Other study ID # KY-20232219-C-1
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date August 21, 2023
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Xijing Hospital of Digestive Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 184
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
Fenofibrate
Fenofibrate 200 mg/day
Placebo
1 tablet/ day
UDCA
UDCA 13-15mg/kg/day

Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Han Ying

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with biochemical response The normalisation of Alkaline Phosphatase 48 weeks
Secondary Percentage of patients having biochemical response The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks 4, 12, 24 and 36weeks
Secondary Assessment of the pruritus Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome) 4, 12, 24, 36, and 48 weeks
Secondary Assessment of the fatigue Change From Baseline in Fatigue as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome) 4, 12, 24, 36, and 48 weeks
Secondary Percentage of patients having biological or clinical adverse events Increase of creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase 4, 12, 24, 36, and 48 weeks
Secondary Survival without transplantation and hepatic impairment Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death 48 weeks
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