Active, not recruitingNCT06174402Updated Aug 20, 2026

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

A Phase 2/3 interventional study of Fenofibrate and Placebo in Primary Biliary Cholangitis, sponsored by Han Ying. Active, not recruiting at 12 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Han Ying · Phase 2/3, Interventional, and Treatment

From the registry’s dates

Registered 3 months after the study started (first participant enrolled Aug 2023, registered Dec 2023).

Phase: Phase 2/3
Study type: Interventional
Enrollment: 184
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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)

Conditions studied

Primary Biliary Cholangitis

Browse trials for

Liver Cirrhosis, Biliary 208

In context

Liver Cirrhosis, Biliary

208 studies on the registry are indexed under Liver Cirrhosis, Biliary; 44 are open to participants now.

This study's planned enrollment of 184 is above the median of 60 across 150 interventional studies indexed under Liver Cirrhosis, Biliary.

Browse Liver Cirrhosis, Biliary studies →

Lead sponsor

Han Ying is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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 ULN\< ALP \<= 1.67 ULN
Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Exclusion criteria

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

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 184 participants (estimated)

Study arms

Experimental
Fenofibrate-ursodesoxycholic acid（UDCA）
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
Drug: Fenofibrate · Drug: UDCA
Placebo comparator
Placebo-UDCA
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
Drug: Placebo · Drug: UDCA

Interventions

DrugFenofibrate
Fenofibrate 200 mg/day
DrugPlacebo
1 tablet/ day
DrugUDCA
UDCA 13-15mg/kg/day

What researchers measure

Primary outcomes

Percentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Time frame: 48 weeks

Secondary outcomes

Percentage of patients having biochemical response
The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks
Time frame: 4, 12, 24 and 36weeks
Changes in biochemical indicators compared to baseline
Changes in ALP, AST, ALT, GGT, TBIL compared to baseline
Time frame: 4,12,24,36 and 48 weeks
Assessment of the pruritus
Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Pruritus. (0-10, higher scores mean a worse outcome)
Time frame: 4, 12, 24, 36, and 48 weeks
Assessment of the fatigue
Change From Baseline in Fatigue as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue. (0-10, higher scores mean a worse outcome)
Time frame: 4, 12, 24, 36, and 48 weeks
Prognostic score
The prognostic score( UK-PBC score) at 48 weeks of treatment
Time frame: 48 weeks
Prognostic score
The prognostic score( GLOBE PBC score) at 48 weeks of treatment
Time frame: 48 weeks
Changes in liver stiffness
Changes of liver stiffness measured by Fibrotouch/Fibroscan after 48 weeks of treatment
Time frame: 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase
Time frame: 4, 12, 24, 36, and 48 weeks
Survival without transplantation and hepatic impairment
Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death
Time frame: 48 weeks

Study locations

12 sites

The second hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nanjing Second Hospital
Nanjing, Jiangsu, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
Xijing Hospital
Xi'an, Shaanxi, China
Yan'an University Affiliated Hospital
Yan’an, Shanxxi, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Peking Union Medical College Hospital
Beijing, China
The First Hospital of China Medical University
Shenyang, China
Tianjin Third Central Hospital
Tianjin, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06174402
Lead sponsor: Han Ying
Responsible party: Han Ying (Professor, Xijing Hospital of Digestive Diseases) — Sponsor-investigator
First posted: Dec 18, 2023
Start date: Aug 21, 2023
Primary completion: Sep 2026 (estimated)
Completion: Dec 31, 2026 (estimated)
Last update: Aug 20, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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