Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genfit
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Must have provided written informed consent
2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
* History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
* Positive Anti-Mitochondrial Antibodies (AMA) titers (\> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
* Liver biopsy consistent with PBC
3. ALP \>= 1.67x upper limit of normal (ULN)
4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit
5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.
You may not be if
1. History or presence of other concomitant liver diseases
2. Screening creatine phosphokinase (CPK) \> upper limits of normal (ULN)
6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate \[eGFR\] of less than 60 mL/min/1.73 m\^2).
7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
8. Platelet count \<150 X 10\^3/microliter
9. Albumin \<3.5 g/dL
10. Presence of clinical complications of PBC or clinically significant hepatic decompensation
11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
12. Known history of human immunodeficiency virus (HIV) infection
13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
Clareo Health | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
