Primary Biliary Cholangitis (PBC)
Conditions
Interventions
80 mg of Elafibranor administered orally once a day. The participant will be treated for 52 weeks during the treatment period followed by a variable treatment extension period of 2 to 5 years (the max
Sponsors
Allan Richard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Must have provided written informed consent and agree to comply with the study protocol. -Japanese male or female participants aged 18 to 75 years inclusive at Screening Visit 1 (SV1) -PBC diagnosis as described in the study protocol -ALP >=1.67xULN (mean value based on samples collected at SV1 and SV2). -TB =3 months) prior to screening, or unable to tolerate UDCA treatment (no UDCA for >=3 months) prior to screening (per country standard-of-care dosing). -If on colchicine, must be on a stable dose for >=3 months prior to screening. -Medications for management of pruritus (for example, cholestyramine, rifampicin, naltrexone, sertraline or nalfurafine hydrochloride) must be on a stable dose for >=3 months prior to screening. -Participants taking statins or ezetimibe must be on a stable dose for >=2 months prior to screening. -Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
Exclusion criteria: -History or presence of other concomitant liver disease -Participants with known cirrhosis who have a Child-Pugh B or C classification. -Participants with cirrhosis with Child-Pugh A classification are allowed. -History or presence of clinically significant hepatic decompensation -Medical conditions that may cause non-hepatic increases in ALP (for example, Paget's disease) or which may diminsh life expectancy to 5xULN. -For participants with aminotransferases or TB >ULN at SV1, variability (between SV1 and SV2) of aminotransferases or TB >40%. -SV1 value albumin ULN and albumin 1.3 due to altered hepatic function. -SV1 creatine phosphokinase (CPK) >2xULN. -SV1 serum creatinine >1.5 mg/dL. -Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as participants with markers of kidney failure damage or estimated glomerular filtration rate (eGFR) 20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of liver cancer. -Known hyperse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment at Week 52 defined as ALP =15% | — |
Contacts
Public ContactClinical trial contact
ICON Clinical Research GK
Outcome results
None listed