Prospective Observational Study Assessing the Impact of Elafibranor on Fatigue, Work Productivity/Activity Impairment, and Pruritus in Patients With PBC

Study identification

• EU PAS number:
  EUPAS1000001071
• Study ID:
  1000001071
• Official title and acronym:
  Prospective Observational Study Assessing the Impact of Elafibranor on Fatigue, Work Productivity/Activity Impairment, and Pruritus in Patients With PBC
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study is to understand how tiredness changes in adults with Primary Biliary Cholangitis (PBC) after starting elafibranor in routine clinical practice.; ; PBC is a rare liver disease that damages the small bile ducts in the liver.; ; Participants will complete questionnaires before starting elafibranor and at Months 3, 6 and 12. The questionnaires will ask about tiredness, itching, work and daily activities. Each participant will be followed for approximately 12 months.
• Study status:
  Planned

Research institutions and networks

Institutions

Ipsen Pharma

This study is conducted by PicnicHealth, the research vendor, on behalf of the Sponsor.

Study timelines

Date when funding contract was signed

Planned:16/12/2025

Actual:16/12/2025

Study start date

Planned:02/11/2026

Date of interim report, if expected

Planned:31/08/2027

Date of final study report

Planned:21/02/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

No information provided.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CLIN-60190-477