Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

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Xijing Hospital of Digestive Diseases

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Primary Biliary Cholangitis

Treatments

Drug: Fenofibrate
Drug: UDCA

Study type

Interventional

Funder types

Other

Identifiers

NCT06365424
KY20151230-5-1

Details and patient eligibility

About

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

Enrollment

117 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

117 participants in 2 patient groups

UDCA
Active Comparator group
Treatment:
Drug: UDCA
UDCA+Fenofibrate
Experimental group
Treatment:
Drug: UDCA
Drug: Fenofibrate

Trial contacts and locations

1

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Central trial contact

Yansheng Liu, MD

Data sourced from clinicaltrials.gov

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