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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06365424
Other study ID # KY20151230-5-1
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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