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New treatment option for Primary Biliary Cholangitis
Official title Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
ClinicalTrials.gov ID: NCT05749822
What this study is testing
What is Fenofibrate 200mg?
Fenofibrate 200mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for primary biliary cholangitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- 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...
- Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
See the full eligibility 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...
- Abnormal laboratory inspection indicators (2 out of 4): 1) PLT \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Yan’an, Shaanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
- Tianjin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Shenyang, Liaoning, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.