Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study

Xijing Hospital of Digestive Diseases

Status and phase: Enrolling; Phase 3

Conditions: Primary Biliary Cholangitis (PBC)

Treatments: Drug: Fenofibrate in Combination With Ursodeoxycholic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06755541

KY20222274-C-1-1

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must have given written informed consent (signed and dated)
2. Completed in a PBC study with fenofibrate(NCT05751967)
3. 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

1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

fenofibrate

Experimental group

Description:

Experimental: Fenofibrate 200 mg Capsules

Treatment:

Drug: Fenofibrate in Combination With Ursodeoxycholic Acid