Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

Primary Biliary Cholangitis Clinical Trial

Official title:

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365424
• Other study ID #: KY20151230-5-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 8, 2017
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Xijing Hospital of Digestive Diseases
• Contact: Yansheng Liu, MD
• Phone: +862984771539
• Email: liuyansheng506[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must have given written informed consent (signed and dated)
• Participated in the PBC study with fenofibrate (NCT02823353)
• Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

• Treatment-related adverse event (AE) leading to fenofibrate discontinuation
• A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
• Known history of other liver diseases
• For females, pregnancy or breast-feeding
• Long-term use of immunosuppressive agents
• Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• Fenofibrate
Fenofibrate (200 mg/day)
• UDCA
Ursodeoxycholic acid (13-15 mg/kg/day)

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events (TEAEs)		Through study completion, up to 120 Months
Primary	Percentage of patients with biochemical response	The normalisation of Alkaline Phosphatase	Through study completion, up to 120 Months