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Recruiting NCT06447168

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

— Observational Primary Biliary Cholangitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Biliary Cholangitis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Canada, Germany +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.

Overview

This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).

Primary outcome measures

  • Percentage of participants with response to treatment [Time frame: At month 6]
Secondary outcome measures (12)
  • Percentage of participants with normalization of ALP levels [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Percentage of participants with response to treatment [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visits]
  • Change from baseline in liver function parameters: Serum levels of alanine aminotransferase (ALT) [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in liver function parameters: Serum levels of Aspartate aminotransferase (AST) [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in liver function parameters: Serum levels of Gamma-glutamyl transferase (GGT) [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in liver function parameters: Serum levels of TB [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in liver function parameters: Conjugated (direct) bilirubin [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in liver function parameters: Serum levels of creatinine [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in liver function parameters: Serum levels of albumin [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in pruritus based on PBC Itch score [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in fatigue based on functional assessment of chronic illness therapy-fatigue (FACIT-Fatigue) scale [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]
  • Change from baseline in sleep based on Pittsburgh sleep quality index (PSQI) [Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit]

Eligibility criteria

Inclusion criteria

  • Participant has provided written informed consent and agrees to comply with the study protocol.
  • Participant with PBC diagnosis.
  • Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.
  • If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.

Exclusion criteria

  • Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.
  • Participant with known hypersensitivity to the product or to any of its excipients.
  • Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 20 centers
  • Southern California Research Center — Coronado
  • Cedars-Sinai Medical Center — Los Angeles
  • University of California Davis Medical Center — Sacramento
  • South Denver Gastroenterology,P.C. — Englewood
  • Yale University School of Medicine — New Haven
  • Schiff Center for Liver Diseases - University of Miami — Miami
  • Beth Israel Deaconess Medical Center, Liver Research Center — Boston
  • Virtua Center for Liver Disease - Cherry Hill — Cherry Hill
  • … and 12 more centers
United Kingdom · 9 centers
  • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board — Aberdeen
  • Belfast Health and Social Care Trust - Royal Victoria Hospital — Belfast
  • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust — Birmingham
  • Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation — Bradford
  • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust — Hull
  • King's College Hospital NHS Foundation Trust — London
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital — Newcastle
  • Queen's Medical Centre - Nottingham University Hospitals NHS Trust — Nottingham
  • … and 1 more center
Germany · 8 centers
  • Charite Universitatsmedizin Berlin — Berlin
  • DRK Kliniken Berlin Mitte — Berlin
  • Klinikum der Johann Wolfgang Goethe-Universitaet — Frankfurt
  • Studiengesellschaft BSF — Halle
  • Gastroenterologsiche Studiengesellschaft Herne — Herne
  • Universitaet des Saarlandes — Homburg
  • Universitaetsklinikum Leipzig — Leipzig
  • Hospital of the Merciful Brothers Trier — Trier
Italy · 7 centers
  • ASST-Ospedale Papa Giovanni XXIII — Bergamo
  • Ospedale Garibaldi Nesima — Catania
  • Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) — Florence
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
  • Ospedale Maggiore Della Carita — Novara
  • A. Gemelli University Hospital, Catholic University of the Sacred Heart — Roma
  • Fondazione Policlinico Universitario Campus Bio-Medico — Roma
Spain · 6 centers
  • Hospital de Torrecardenas — Almería
  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial) — Barcelona
  • Hospital Universitario Vall d'Hebron — Barcelona
  • Hospital General Universitario Gregorio Maranon (HGUGM) — Madrid
  • Complexo Hospitalario Universitario de Pontevedra — Pontevedra
  • Instituto De Investigacion Marques De Valdecilla (IDIVAL) — Santander
Canada · 5 centers
  • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) — Montreal
  • University of Calgary — Calgary
  • London Health Sciences Centre (LHSC) - University Hospital — London
  • The Ottawa Hospital - General Campus — Ottawa
  • (G.I.R.I) GI Research Institute Foundation — Vancouver
Greece · 5 centers
  • General Hospital of Athens Laiko — Athens
  • University Hospital of Heraklion — Heraklion
  • University General Hospital of Larissa — Larissa
  • University General Hospital of Patras — Pátrai
  • Ippokratio General Hospital of Thessaloniki — Thessaloniki
South Korea · 5 centers
  • Pusan National University Hospital (PNUH) — Busan
  • Seoul National University Bundang Hospital (SNUBH) — Seongnam-si
  • Samsung Medical Center — Seoul
  • Seoul National University Hospital — Seoul
  • Severance Hospital, Yonsei University Health System — Seoul
United Arab Emirates · 4 centers
  • Clemenceau Medical Center Hospital — Dubai
  • Mediclinic Airport Road Hospital — Dubai
  • Rashid Hospital — Dubai
  • Sheikh Shakhbout Medical City — Dubai
Austria · 3 centers
  • Medizinische Universitaetsklinik Graz — Graz
  • Medical University Innsbruck — Innsbruck
  • Ordensklinikum Linz GmbH Barmherzige Schwestern — Linz
Australia · 2 centers
  • Royal Prince Alfred Hospital — Camperdown
  • St Vincent's Hospital — Fitzroy

Identifiers

NCT: NCT06447168 · CLIN-60190-461

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗