The seladelpar registry will collect real-world data of patients with PBC diagnosis treated with seladelpar in the real-life scenario in Germany and Switzerland.
Age ≥ 18 years
Diagnosis of PBC according to EASL criteria
Treatment with seladelpar
Written informed consent
current or previous participation in a phase I to IV interventional clinical trial for seladelpar treatment of PBC
Pregnancy and breastfeeding
patients with Primary Biliary Cholangitis (PBC) treated with seladelpar
Cohort
Other
Not listed
biochemical response according to POISE criteria
The endpoint "POISE criteria" is reached if at the 48 week visit, ALP \< 1.67 x ULN and at least 15% lower than week 0 value from the start of seladelpar
alternative definitions of response at the 48 week visit for patients with ALP levels > 1.5 or > 1.0 x ULN or bilirubin levels > 1.0 or > 0.6 x ULN at week 0 of seladelpar therapy
* ALP \< 1.5 x ULN * ALP \< 1.0 x ULN * bilirubin \< 1.0 x ULN * bilirubin \< 0.6 x ULN
Improvement in Vibration Controlled Transient Elastography (VCTE)
Improvement in Vibration Controlled Transient Elastography (VCTE) as a surrogate for fibrosis. The mean individual relative change in VCTE values from week 0 to 48 weeks will be calculated. Furthermore, for patients with values above the cut-offs 8, 10 and 15 kPa at week 0, the proportion who then fall below these cut-offs will be provided.
indication for seladelpar
The treating physician provides the indication for seladalpar as one of "biochemical response", "pruritus", "both".
AEs and SAEs will be classified using the Medical Dictionary for Regulatory Activities (MedDRA)
AEs and SAEs will be classified using the Medical Dictionary for Regulatory Activities (MedDRA)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
