NCT06755151

Brief Summary

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
117mo left

Started Jan 2024

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jan 2024Dec 2035

Study Start

First participant enrolled

January 17, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

11.9 years

First QC Date

December 24, 2024

Last Update Submit

January 6, 2026

Conditions

Primary Biliary Cholangitis (PBC)

Outcome Measures

Primary Outcomes (1)

  • Treatment emergent adverse events (TEAEs)

    Through study completion, up to 120 Months

Secondary Outcomes (3)

  • Death

    120 months

  • Liver transplantation

    120 months

  • Normalization of ALP

    120 months

Study Arms (1)

fenofibrate

EXPERIMENTAL
Drug: Fenofibrate

Interventions

FenofibrateDRUG

Fenofibrate 200mg

fenofibrate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have given written informed consent (signed and dated)
  • Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
  • ALP\> 1\*ULN
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Central Study Contacts

Yansheng Liu

CONTACT

862984771509liuyansheng506@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 1, 2025

Study Start

January 17, 2024

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

CN(1)