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

NCT ID: NCT06755541

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2035-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Primary Biliary Cholangitis (PBC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fenofibrate

Experimental: Fenofibrate 200 mg Capsules

Group Type EXPERIMENTAL

Fenofibrate in Combination With Ursodeoxycholic Acid

Intervention Type DRUG

Experimental: Fenofibrate 200 mg Capsules

Interventions

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Fenofibrate in Combination With Ursodeoxycholic Acid

Experimental: Fenofibrate 200 mg Capsules

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

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Han Ying

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yansheng Liu

Role: CONTACT

862984771539

Facility Contacts

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Liu

Role: primary

862984771509

Other Identifiers

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KY20222274-C-1-1

Identifier Type: -

Identifier Source: org_study_id

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