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원발성 담즙성 담관염(PBC) 환자의 엘라피브라노르 연구 (ELATIVE)

2026년 10월 20일 업데이트: Ipsen

우르소데옥시콜린산에 부적절한 반응 또는 불내성을 보이는 원발성 담즙성 담관염 환자에서 엘라피브라노르 80mg의 효능 및 안전성을 평가하기 위한 이중맹검, 무작위, 위약 대조 연구 및 공개 라벨 장기 연장

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease).

PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.

The main aim of this study is to determine if elafibranor (the study drug) is better than placebo (a dummy treatment) at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also evaluate the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itchy skin (pruritus) and tiredness (fatigue).

This study has two main parts:

Part 1 will compare a daily dose of elafibranor to a daily dose of placebo and will last between a minimum of one year and a maximum of two years.

Part 2, all participants will receive elafibranor for a period of up to 5 years or until the total treatment duration (part 1 and part 2) reaches 6 years, whichever occurs first.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

161

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 남아프리카
      • Cape Town, 남아프리카, 7800
        • Mediclinic Constantiaberg, North Suites
    • Western Cap
      • Cape Town, Western Cap, 남아프리카, 7925
        • Groote Schuur Hospital, University of Cape Town - Clinical Research Centre
    • Western Cape
      • Cape Town, Western Cape, 남아프리카, 7530
        • Tiervlei Trial Centre
  • 독일
      • Berlin, 독일, 10825
        • Gastro - Sudien
      • Berlin, 독일, 13353
        • Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik
      • Frankfurt, 독일, 60590
        • Universitätsklinikum Frankfurt
      • Hanover, 독일, 30625
        • Medizinische Hochschule Hannover
      • Kiel, 독일, 24146
        • Center for Gastroenterology and Hepatology (GHZ) Kiel
      • Leipzig, 독일, 04103
        • EUGASTRO GmbH
      • Mainz, 독일, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • 미국
    • Arizona
      • Chandler, Arizona, 미국, 85224
        • The Institute for Liver Health
    • California
      • Los Angeles, California, 미국, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, 미국, 90036
        • Ruane Clinical Research Group Inc.
      • Los Angeles, California, 미국, 90033
        • Keck Medical Center of USC
      • Sacramento, California, 미국, 95817
        • University of California, Davis Medical Center
      • San Francisco, California, 미국, 94109
        • California Pacific Medical Center - Sutter Pacific Medical Foundation
    • Colorado
      • Aurora, Colorado, 미국, 840045
        • University of Colorado Denver and Hospital
      • Englewood, Colorado, 미국, 80113
        • South Denver Gastroenterology, P.C.
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • Yale School of Medicine, Digestive Diseases
    • Florida
      • Jacksonville, Florida, 미국, 32256
        • Encore Borland-Groover Clinical Research
      • Miami, Florida, 미국, 33136
        • Schiff Center for Liver Diseases/University of Miami
    • Georgia
      • Atlanta, Georgia, 미국, 30309
        • Digestive Healthcare of Georgia
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, 미국, 02215
        • Beth Israel Deaconess Medical Center (BIDMC)
    • Michigan
      • Novi, Michigan, 미국, 48377
        • Henry Ford Health System
    • Missouri
      • St Louis, Missouri, 미국, 63104
        • Saint Louis University
    • New York
      • New Hyde Park, New York, 미국, 11042-11114
        • UPMC Center for Liver Diseases
      • New York, New York, 미국, 10016
        • NYU Langone Health / NYU Grossman School of Medicine
      • New York, New York, 미국, 10032
        • Columbia University Medical Center - Center for Liver Disease and Transplantation
      • New York, New York, 미국, 10065
        • The New York-Presbyterian Hospital, David H. Koch Center
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Duke University Medical Center
      • Huntersville, North Carolina, 미국, 28078
        • Carolinas Centre for Liver disease/ Atrium Health
    • Ohio
      • Cincinnati, Ohio, 미국, 45249
        • Consultants for Clinical Research
      • Cleveland, Ohio, 미국, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, 미국, 43210-1240
        • The Ohio State University Wexner Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, 미국, 17033
        • Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, 미국, 19107
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Medical University of South Carolina- College of Medicine
    • Tennessee
      • Nashville, Tennessee, 미국, 37232
        • Vanderbilt Digestive Disease Center
    • Texas
      • Arlington, Texas, 미국, 76012
        • Texas Clinical Research Institute, LLC
      • Dallas, Texas, 미국, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • Dallas, Texas, 미국, 75234
        • Liver Center of Texas, PLLC
      • Dallas, Texas, 미국, 75390-8575
        • The University of Texas Southwestern Medical Center-IDS Aston Pharmacy
      • Fort Worth, Texas, 미국, 76104
        • Texas Digestive Disease Consultants dba GI Alliance
      • Houston, Texas, 미국, 77030
        • Liver Associates of Texas, P.A.
      • Houston, Texas, 미국, 77030
        • St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research
      • San Antonio, Texas, 미국, 78215
        • American Research Corporation
      • Victoria, Texas, 미국, 77904
        • Gastro health & Nutrition-Victoria
    • Utah
      • Murray, Utah, 미국, 84107
        • Intermountain Medical Center - Transplant Services
      • Salt Lake City, Utah, 미국, 84132
        • University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition
    • Virginia
      • Charlottesville, Virginia, 미국, 22908
        • University of Virginia Medical Center
      • Newport News, Virginia, 미국, 23602
        • Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads
      • Richmond, Virginia, 미국, 23298
        • Virginia Commonwealth University Clinical Research Services Unit (CRSU)
      • Richmond, Virginia, 미국, 23226
        • Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond
    • Washington
      • Seattle, Washington, 미국, 98105
        • Liver Institute Northwest
  • 벨기에
      • Brussels, 벨기에, 1070
        • Hôpital Erasme
      • Edegem, 벨기에, 2650
        • Antwerp University Hospital
      • Ghent, 벨기에, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, 벨기에, 3000
        • University Hospital Leuven
  • 브라질
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, 브라질, 90035-903
        • Hospital de Clínicas de Porto Alegre
    • São Paulo
      • São Paulo, São Paulo, 브라질, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
  • 스위스
      • Bern, 스위스, 3010
        • Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie
      • Lugano, 스위스, 6900
        • Fondazione Epatocentro Ticino
  • 스페인
      • Barcelona, 스페인, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, 스페인, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, 스페인, 28046
        • Hospital Universitario La Paz
      • Madrid, 스페인, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, 스페인, C.P 28222
        • Hospital Universitario Puerta de Hierro -Madrid
      • Pontevedra, 스페인, 36071
        • Complexo Hospitalario Universitario de Pontevedra
      • San Sebastián, 스페인, 20014
        • Hospital Universitario Donostia
      • Santander, 스페인, 39010
        • Hospital Universitario Marqués de Valdecilla
      • Seville, 스페인, 41013
        • Hospital Universitario Virgen del Rocio
  • 아르헨티나
    • Buenos Aires
      • CABA, Buenos Aires, 아르헨티나, 1199
        • Hospital Italiano de Buenos Aires
      • CABA, Buenos Aires, 아르헨티나, C1280AEB
        • Hospital Británico de Buenos Aires
      • Caba, Buenos Aires, 아르헨티나, C1118AAT
        • Hospital Alemán
      • La Plata, Buenos Aires, 아르헨티나, 1900
        • Hospital Italiano de La Plata
    • Mendoza Province
      • Godoy Cruz, Mendoza Province, 아르헨티나, 5547
        • Hospital Espanol De Mendoza
    • Santa Fe Province
      • Rosario, Santa Fe Province, 아르헨티나, S2002KDS
        • Hospital Provincial del Centenario
  • 영국
      • Belfast, 영국, BT12 6BA
        • Belfast Health and Social Care Trust-Royal Victoria Hospital
      • Camberley, 영국, GU16 7UJ
        • Frimley Health NHS Foundation Trust - Frimley Park Hospital
      • Cambridge, 영국, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
      • Hull, 영국, HU32J
        • Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary
      • London, 영국, SE5 9RS
        • King's College Hospital. King's College NHS Foundation Trust
      • Nottingham, 영국, NG72UH
        • Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)
      • Plymouth, 영국, PL6 8DH
        • Plymouth Hospitals NHS Trust, Derriford Hospital
    • Newcastle
      • Newcastle upon Tyne, Newcastle, 영국, NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital
  • 이탈리아
      • Bologna, 이탈리아, 40138
        • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
      • Milan, 이탈리아, 20142
        • Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia
      • Monza, 이탈리아, 20900
        • ASST Monza - Ospedale San Gerardo, Gastroenterologia
      • Padova, 이탈리아, 35128
        • Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia
      • Palermo, 이탈리아, 90127
        • Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica
    • Località Baggiovara
      • Modena, Località Baggiovara, 이탈리아, 41126
        • Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale
  • 칠레
      • Santiago, 칠레, 7550000
        • Clínica Universidad de los Andes
    • Coquimbo Region
      • La Serena, Coquimbo Region, 칠레, 1700000
        • Hospital de La Serena
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, 칠레, 8330034
        • Centro de Investigacion Clinica Universidad Catolica CICUC
      • Santiago, Santiago Metropolitan, 칠레, 8320000
        • Hospital Clínico Universidad de Chile
    • Valparaiso
      • Viña del Mar, Valparaiso, 칠레, 2540364
        • Centro de Investigaciones Clinicas (CIC)
  • 캐나다
      • Montreal, 캐나다, H2X 0A9
        • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4Z6
        • University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V5Z IM9
        • Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
    • Manitoba
      • Winnipeg, Manitoba, 캐나다, R3E 3P4
        • Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre
  • 터키 (Türkiye)
      • Ankara, 터키 (Türkiye), 06230
        • Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.
    • Bornova
      • Izmir, Bornova, 터키 (Türkiye), 35100
        • Ege Universitesi Tip Fakultesi Hastanesi
    • Pendik
      • Istanbul, Pendik, 터키 (Türkiye), 34890
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali
  • 프랑스
      • Amiens, 프랑스, 80054
        • CHU Amiens Picardie
      • Créteil, 프랑스, 94000
        • Hôpital Henri Mondor
      • Grenoble, 프랑스, 38043
        • CHU Grenoble Alpes - Hôpital Albert Michallon
      • Orléans, 프랑스, 45067
        • Centre Hospitalier Régional d'Orléans
      • Paris, 프랑스, 75012
        • Hôpital Saint-Antoine
      • Paris, 프랑스, 75014
        • Hôpital Cochin
      • Paris, 프랑스, 75651
        • Hôpital Pitié-Salpétrière
      • Pessac, 프랑스, 33604
        • Hôpital Haut Lévêque
      • Reims, 프랑스, 51092
        • Hôpital Robert Debré - CHU de Reims
      • Strasbourg, 프랑스, 67200
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria

  • Males or females age of 18 to 75 years (inclusive)
  • Definite or probable Primary biliary cholangitis (PBC) diagnosis
  • Alkaline phosphatase (ALP) ≥ 1.67x upper limit of normal (ULN)
  • Total bilirubin (TB) ≤ 2x ULN
  • Ursodeoxycholic acid (UDCA) for at least 12 months (stable dose ≥ 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)
  • Must have PBC Worst Itch Numeric rating scale (NRS) collected prior to randomization
  • Females participating in this study must be of non-child bearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the last drug intake

Exclusion Criteria:

  • History or presence of other concomitant liver disease
  • Clinically significant hepatic decompensation, including patients with complications of cirrhosis/portal hypertension
  • Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to < 2 years, including known cancers
  • Patient has a positive test for HIV Type 1 or 2 at screening, or patient is known to have tested positive for HIV
  • Evidence of any other unstable or untreated clinically significant disease
  • History of alcohol abuse
  • For female patients: known pregnancy or lactating
  • Use of fibrates and glitazones within 2 months prior to screening
  • Use of Obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs
  • (including α-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin) within 3 months prior to screening
  • Use of antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines within 12 months prior to screening
  • For patients with previous exposure to OCA, OCA should be discontinued 3 months prior to screening
  • Patients who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to screening; for patients with previous exposure to seladelpar, seladelpar should be discontinued 3 months prior to screening
  • Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) values > 5 x ULN
  • For patients with AT or TB>ULN at SV1, variability of AT or TB > 40% (see section 3.5.1)
  • Albumin<3.0 g/dl
  • Severely advanced patients according to Rotterdam criteria (TB > ULN and albumin <LLN)
  • INR > 1.3 due to altered hepatic function
  • CPK > 2 x ULN
  • Screening serum creatinine > 1.5 mg/dl
  • Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney failure damage or eGFR < 60 mL/min/1.73 m^2) calculated by Modification of diet in renal disease (MDRD)
  • Platelet count < 150 x 10^3/μL
  • AFP > 20 ng/mL with 4-phase liver CT or MRI imaging suggesting presence of liver cancer
  • Known hypersensitivity to the investigational product or to any of the formulation excipients of the elafibranor or placebo tablet Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Elafibranor 80mg double-blind

Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning
의약품: Elafibranor 80mg

Elafibranor 80mg daily

다른 이름들:
  • 이키르보®
위약 비교기: Placebo

Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning
의약품: Placebo

Placebo daily
실험적: Elafibranor 80mg open label

Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning
의약품: Elafibranor 80mg

Elafibranor 80mg daily

다른 이름들:
  • 이키르보®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Response to Treatment Based on Cholestasis Response at Week 52
기간: At Week 52

Cholestasis response was defined as alkaline phosphatase (ALP) < 1.67 x upper limit of normal (ULN) and total bilirubin (TB) <= ULN and ALP decrease from baseline >= 15% at Week 52 and based on the composite strategy imputing non-response for participants who experienced intercurrent events (ICEs) (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52

2차 결과 측정

결과 측정
측정값 설명
기간
Key Secondary Endpoint: Percentage of Participants With Response to Treatment Based on ALP Normalization at Week 52
기간: At Week 52

Response to treatment based on normalization of ALP at Week 52 was defined as percentage of participants with ALP =<1.0× ULN and based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
Key Secondary Endpoint: Change From Baseline in Pruritus Based on PBC Worst Itch Numeric Rating Scale (NRS) Score in Participants With Baseline PBC Worst Itch NRS Score ≥4 to Week 52
기간: Baseline (up to 14 days pre-dose) and Week 52

The PBC Worst Itch NRS is a simple, self-administered patient reported outcome (PRO) questionnaire that measures itch intensity. Participants rate intensity of their worst Itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Total score ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse outcomes. Baseline was defined as the average of the daily PBC Worst itch scores on available data within 14 days prior the day of randomization. Post-baseline data was defined as the average of the daily PBC Worst itch scores on available data in 4-week period intervals (available data every 28 days after the day of first study drug intake).
Baseline (up to 14 days pre-dose) and Week 52
Key Secondary Endpoint: Change From Baseline in Pruritus Based on PBC Worst Itch NRS Score in Participants With Baseline PBC Worst Itch NRS Score ≥4 to Week 24
기간: Baseline (up to 14 days pre-dose) and Week 24

The PBC Worst Itch NRS is a simple, self-administered PRO questionnaire that measures itch intensity. Participants rate intensity of their worst Itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Total score ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse outcomes. Baseline was defined as the average of the daily PBC Worst itch scores on available data within 14 days prior the day of randomization. Post-baseline data was defined as the average of the daily PBC Worst itch scores on available data in 4-week period intervals (available data every 28 days after the day of first study drug intake).
Baseline (up to 14 days pre-dose) and Week 24
Change From Baseline in ALP at Weeks 4, 13, 26, 39 and 52
기간: Baseline (Day 1) and at Weeks 4, 13, 26, 39 and 52

Blood samples were collected at specified timepoints for assessment of ALP. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Weeks 4, 13, 26, 39 and 52
Percentage of Participants With ALP Response From Baseline at Week 52
기간: Baseline (Day 1) and at Week 52

ALP response was defined as ALP decrease from baseline >= 10%; ALP decrease from baseline >= 20% and ALP decrease from baseline >= 40% at Week 52 and based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Percentage of Participants With Response to Treatment According to ALP < 1.5x ULN, ALP Decrease From Baseline >= 40% and TB =<ULN at Week 52
기간: At Week 52

Response to treatment was according to ALP < 1.5x ULN, ALP decrease from baseline >= 40% and TB =<ULN at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
At Week 52
Percentage of Participants With Response to Treatment According to ALP < 3x ULN, Aspartate Aminotransferase (AST) < 2x ULN and TB =< 1 Milligrams Per Deciliter (mg/dL) (Paris I) at Week 52
기간: At Week 52

Response to treatment was according to ALP < 3x ULN, AST < 2x ULN and TB =< 1 mg/dL (Paris I) at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
Percentage of Participants With Response to Treatment According to ALP =< 1.5x ULN, AST =< 1.5x ULN and TB =< 1 mg/dL (Paris II) at Week 52
기간: At Week 52

Response to treatment was according to ALP =< 1.5x ULN, AST =< 1.5x ULN and TB =< 1 mg/dL (Paris II) at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
Percentage of Participants With Response to Treatment According to TB Decrease of 15% Change From Baseline at Week 52
기간: At Week 52

Response to treatment was according to TB decrease of 15% change from baseline at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
At Week 52
Percentage of Participants With Response to Treatment According to Normalization of TB (TB =< ULN) and/or Albumin (ALB >= Lower Limit of Normal [LLN]) (Rotterdam) at Week 52
기간: At Week 52

Response to treatment was according to TB (TB =< ULN) and/or albumin (ALB >= LLN) (Rotterdam) at week 52. Participant was considered as responder at Week 52 only if total bilirubin and albumin were normal. The endpoint was analyzed in participants with abnormal total bilirubin (TB > ULN) or albumin (ALB < LLN) at baseline. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
Percentage of Participants With Response to Treatment According to TB ≤0.6 x ULN at Week 52
기간: At Week 52

Response to treatment was according to TB ≤0.6 x ULN at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
Percentage of Participants With Response to Treatment According to ALP ≤1.67 x ULN and TB ≤1 mg/dL (Momah/ Lindor) at Week 52
기간: At Week 52

Response to treatment was according to ALP ≤1.67 x ULN and TB ≤1 mg/dL (Momah/ Lindor) at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
Percentage of Participants With Response to Treatment According to no Worsening of TB at Week 52
기간: At Week 52

Response to treatment was according to no worsening of TB, which was defined as level of TB <ULN or no increase from baseline of more than 0.1 x ULN at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
Percentage of Participants With Response to Treatment According to Complete Biochemical Response at Week 52
기간: At Week 52

Response to treatment according to complete biochemical response which was defined as <= ULN values of ALP, TB, AST, ALT and ALB, and international normalized ratio (INR) at Week 52. It was based on the composite strategy imputing non-response for participants who experienced ICEs (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
At Week 52
PBC 5-, 10- and 15-year Risk Scores Based on United Kingdom (UK)-PBC Score at Week 52
기간: At Week 52

The UK-PBC risk score was defined by the mean percentage risk that a PBC participant treated with UDCA would develop liver failure requiring liver transplantation in 5, 10, and 15 years from diagnosis. It is calculated from the following equation at week 52 as follows: UK-PBC score = 0.0287854*(alpEPxULN-1.722136304) - 0.0422873*([{altastEP x ULN/10}^-1] - 8.675729006) + 1.4199 * (LN(bilEPxULN /10)+2.709607778) - 1.960303*(alb x LLN -1.17673001)-0.4161954*(plt x LLN -1.873564875). The survival S(t) for any given participants was then calculated by S(t) = S0(t) exp(UK-PBC score). Here, alpEP x ULN=ALP /Upper Level Normal ALP at the timepoint, altastEPxULN=(ALT, AST or TA) /upper level normal of the value at the timepoint, bilEP x ULN=bilirubin /upper level normal bilirubin at the timepoint, alb x LLN=alb /alb lower level normal at baseline and plt x LLN=plt/plt lower level normal at baseline. Lower UK-PBC score predicts lower risk and better prognosis.
At Week 52
Global PBC Study Group (GLOBE) Score at Week 52
기간: At Week 52

The GLOBE score was a validated risk assessment tool providing an estimate of transplant-free survival for participants with PBC. It was developed by the Global PBC Study Group using Cox regression model on over 4,000 participants with PBC. It is calculated from the following equation at week 52 as follows: GLOBE score = 0.044378 * age at start of ursodeoxycholic acid (UDCA) therapy + 0.93982 * LN (TB x ULN) + 0.335648 * LN (ALP x ULN) - 2.266708 * ALB x LLN - 0.002581 * platelet count per 10^9/L) + 1.216865; where TB x ULN = bilirubin/ULN at the timepoint, ALP x ULN = ALP/ULN at the timepoint, ALB x LLN = ALB/LLN at the timepoint, platelet count per 10^9/L = platelet count per 10^9/L at the timepoint. The Lower GLOBE PBC score predicts lower risk and better prognosis.
At Week 52
Change From Baseline in Hepatobiliary Injury and Liver Function as Assessed by AST, ALT, Gamma-glutamyl Transferase (GGT), 5 Prime Nucleotidase (5'-NT), and Fractionated ALP (Hepatic) (H1 and H2) at Week 52
기간: Baseline (Day 1) and at Week 52

Hepatobiliary injury and liver function were assessed as measured by AST, ALT, GGT, 5'-NT, and fractionated ALP (hepatic) (H1 and H2). Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by Total and Conjugated Bilirubin at Week 52
기간: Baseline (Day 1) and at Week 52

Hepatobiliary injury and liver function were assessed as measured by total and conjugated bilirubin. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by Albumin at Week 52
기간: Baseline (Day 1) and at Week 52

Hepatobiliary injury and liver function were assessed as measured by albumin. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by INR at Week 52
기간: Baseline (Day 1) and at Week 52

Hepatobiliary injury and liver function were assessed as measured by INR. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Biomarkers of Inflammation as Measured by High-sensitivity C-reactive Protein (hsCRP) at Week 52
기간: Baseline (Day 1) and at Week 52

Biomarkers of inflammation were assessed as measured by hsCRP. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Biomarkers of Inflammation as Measured by Fibrinogen and Haptoglobin at Week 52
기간: Baseline (Day 1) and at Week 52

Biomarkers of inflammation were assessed as measured by fibrinogen and haptoglobin. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Biomarkers of Inflammation as Measured by Tumor Necrosis Factor Alpha at Week 52
기간: Baseline (Day 1) and at Week 52

Biomarkers of inflammation were assessed as measured by TNF-alpha. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Immune Response as Measured by Immunoglobulin (Ig)G and IgM at Week 52
기간: Baseline (Day 1) and at Week 52

Immune response was assessed as measured by IgG and IgM. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Biomarkers and Non-invasive Measures of Hepatic Fibrosis as Measured by Enhanced Liver Fibrosis (ELF) and Plasminogen Activator Inhibitor-1 (PAI-1) at Week 52
기간: Baseline (Day 1) and at Week 52

Biomarkers and non-invasive measures of hepatic fibrosis were assessed as measured by ELF: hyaluronic acid [HA], type 2 procollagen peptide [PIINP], tissue inhibitor of metalloproteinases-1[TIMP-1]) and PAI-1. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Biomarkers and Non-invasive Measures of Hepatic Fibrosis as Measured by Cytokeratin-18 (CK-18) at Week 52
기간: Baseline (Day 1) and at Week 52

Biomarkers and non-invasive measures of hepatic fibrosis were assessed as measured by CK-18 (M30 and M65). Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Biomarkers and Non-invasive Measures of Hepatic Fibrosis as Measured by Transforming Growth Factor Beta (TGF-beta) at Week 52
기간: Baseline (Day 1) and at Week 52

Biomarkers and non-invasive measures of hepatic fibrosis were assessed as measured by TGF-beta. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Liver Stiffness Measured by Transient Elastography (TE) at Week 52
기간: Baseline (Day 1) and at Week 52

FibroScan® TE device (Echosens, Paris, France) is a non-invasive technique used to measure liver stiffness, which correlated with fibrosis. Baseline was defined as the last non-missing value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Lipid Parameters at Week 52
기간: Baseline (Day 1) and at Week 52

Blood samples were collected at specified timepoints for assessment of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and triglycerides (TG). Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
기간: Baseline (Day 1) and at Week 52

Blood samples were collected at specified timepoints for assessment of FPG. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Bile Acids and Biomarkers of Bile Acid Synthesis at Week 52
기간: Baseline (Day 1) and at Week 52

Blood samples were collected at specified timepoints for assessment bile acids and biomarkers of bile acid synthesis. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline at Week 52 in Bile Acids and Biomarkers of Bile Acid Synthesis as Measured by 7 Alpha-hydroxy-4-cholesten-3-one (C4) at Week 52
기간: Baseline (Day 1) and at Week 52

Blood samples were collected at specified timepoints for assessment of bile acids and biomarkers of bile acid synthesis as measured by C4. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Bile Acids and Biomarkers of Bile Acid Synthesis as Measured Fibroblast Growth Factor 19 at Week 52
기간: Baseline (Day 1) and at Week 52

Blood samples were collected at specified timepoints for assessment bile acids and biomarkers of bile acid synthesis as measured by Fibroblast Growth Factor 19. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Percentage of Participants With Response in PBC Worst Itch NRS Score at Weeks 24 and 52
기간: Baseline (up to 14 days pre-dose) and at Week 24 and Week 52

The PBC Worst Itch NRS is a simple, self-administered PRO questionnaire that measures itch intensity. Participants rate intensity of their worst Itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Total score ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse outcomes. Response to PBC Worst Itch NRS was according to clinically meaningful change at least 30% reduction; one point, two points or three points decrease in score from baseline in participants with a baseline NRS score ≥4. Baseline was defined as the average of the daily PBC Worst itch scores on available data within 14 days prior the day of randomization. Post-baseline data was defined as the average of the daily PBC Worst itch scores on available data in 4-week period intervals (available data every 28 days after the day of first study drug intake).
Baseline (up to 14 days pre-dose) and at Week 24 and Week 52
Percentage of Participants With no Worsening of Pruritus as Measured by the PBC Worst Itch NRS Score at Weeks 24 and 52
기간: Baseline (up to 14 days pre-dose) and at Week 24 and Week 54

The PBC Worst Itch NRS is a simple, self-administered PRO questionnaire that measures itch intensity. Participants rate intensity of their worst Itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Total score ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse outcomes. Baseline was defined as the average of the daily PBC Worst itch scores on available data within 14 days prior the day of randomization. Post-baseline data was defined as the average of the daily PBC Worst itch scores on available data in 4-week period intervals (available data every 28 days after the day of first study drug intake). A worsening of Pruritus was defined by a positive change from baseline in PBC Worst Itch NRS score greater than 2 at week 24 and 52.
Baseline (up to 14 days pre-dose) and at Week 24 and Week 54
Change From Baseline in 5-D Itch at Week 52
기간: Baseline (Day 1) and at Week 52

The 5-D Itch scale is a questionnaire that has been validated in several different diseases. It assesses symptoms in terms of 5 domains: duration: score range 1 (less than 6 hours) to 5 (all day); degree: score range 1 (not present) to 5 (unbearable); duration: score range 1 (less than 6 hours) and 5 (all day); direction: score range 1(completely resolved) and 5 (getting worse); disability: score range 1 (never affects or not applicable) and 5 (delays falling asleep and frequently wakes up at night or always affects this activity) and distribution: where the question was to mark where itching is present in body parts over the last two weeks. Participants rated their symptoms over preceding 2-week period on a 1 to 5 scale, with 5 being the most affected. The 5-D Itch total score ranged between 5 (no pruritus) and 25 (most severe pruritus). Higher scores indicated worse outcomes. Baseline= last non-missing value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a at Week 52
기간: Baseline (Day 1) and at Week 52

The PROMIS Fatigue Short Form 7a consists of seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Participants completed the PROMIS Fatigue Short Form 7a and answered following questions on a scale from 1 (never) to 5 (always) : "How often did you feel tired"; "How often did you experience extreme exhaustion"; "How often did you run out of energy"; "How often did your fatigue limit you at work"; "How often were you too tired to think clearly"; "How often were you too tired to take a bath or shower" and 'How often did you have enough energy to exercise strenuously". T-score values include mean of 50 and standard deviation of 10. The PROMIS Fatigue T-score ranged from 29.4 (best) to 83.2 (worst). Higher scores indicated worse outcomes. Baseline was defined as the last non-missing value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 52
기간: Baseline (Day 1) and at Week 52

The ESS is a short, self-administered questionnaire that consists of 8 questions asking to rate how likely it is to fall asleep in everyday situations (each question can be scored from 0 to 3 points; '0' indicates no chance of dozing and '3' indicates high chance of dozing). It provides a total score which has been shown to relate to the participant's level of daytime sleepiness (total score range 0 [no sleepiness] to 24 points [significant sleepiness]). The total score is the sum of all item scores and ranged from 0 (best) to 24 (worst). Higher scores indicated more chances of sleepiness. Participants were asked to complete the ESS with regard to the level of sleepiness they experienced over approximately the past 7 days. Baseline was defined as the last non-missing value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in PBC-40 at Week 52
기간: Baseline (Day 1) and at Week 52

PBC-40 assess symptoms across 6 domains:symptoms,itch,fatigue,cognitive,emotional and social. Participants responded on verbal response scale,depending on section options range from 'never'/'not at all'/'strongly disagree' to 'always'/'very much'/'strongly agree'.5 items (3/3 in itch domain and 2/10 in social domain)also included a 'does not apply' option.Domains:Symptoms(7 questions)score range 7-35,Itch(3 questions)score range 3-15,Fatigue(11 questions)score range 11-55,Cognitive(6 questions)score range 6-30,Emotional(3 questions)score range 3-15,Social(10 questions)score range 10-50.Score for each domain was provided(total score was not calculated),with each verbal response scale correlating to score of 1-5 per item(0-5 on items with a 'does not apply' option);5=most affected.Individual item scores are summed to give total domain score.Higher scores=worse outcomes.PBC-40 had 4-week recall period.Baseline=last non-missing value on or before first dose of randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Health Utility as Measured by the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 52
기간: Baseline (Day 1) and at Week 52

The EQ-5D-5L is a 6-item, standardized questionnaire that assesses mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and overall health state. The visual analog scale (VAS) of EQ-5D-5L questionnaire is numbered from 0 (worst) to 100 (best). Higher scores indicated better outcomes. Baseline was defined as the last non-missing value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in T-Scores for Bone Mineral Density Assessed by Dual-energy X-ray Absorptiometry (DEXA) Scanning at Week 52
기간: Baseline (Day 1) and at Week 52

DEXA scanning (hip and lumbar) was performed in participants to assess bone mineral density (femoral neck, lumbar and total hip). T-scores were calculated based on actual measured bone density value. The T-score compared a participant's bone density against that of a healthy 30-year-old adult. T-scores were used to determine primary osteoporosis, which exists on its own without any other cause and were divided into 3 categories: low risk, medium risk, and high risk (osteoporosis). T-scores measure the number of minerals in a participant's bone. A participant's level of bone loss was compared to that of a typical, healthy 30-year-old adult. A score ≥-1.0 indicates low risk, medium risk is a score between-2.5 and -1.0, and a high risk/osteoporosis is a score ≤-2.5. A positive change in T-score indicates an improvement in bone mineral density. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Serum Markers of Bone Turnover Carboxy Terminal Crosslinked Telopeptides of Type 1 Collagen [CTX] at Week 52
기간: Baseline (Day 1) and at Week 52

Blood samples were collected at specified timepoints for assessment of serum markers of bone turnover, CTX. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Change From Baseline in Serum Markers of Bone Turnover Type 1 Procollagen Peptide [P1NP]) at Week 52
기간: Baseline (Day 1) and at Week 52

Blood samples were collected at specified timepoints for assessment of serum markers of bone turnover, P1NP. Baseline was defined as the last non-missing central value on or before the first dose of the randomized study medication.
Baseline (Day 1) and at Week 52
Percentage of Participants With Onset of Clinical Outcomes
기간: From Day 1 up to Week 52

Onset of clinical outcomes were described as a composite endpoint composed of the following: model for end stage liver disease sodium (MELD-Na) >14 for participants with baseline MELD-Na <12; liver transplant; uncontrolled ascites requiring treatment; hospitalization for new onset or recurrence of any including, variceal bleed, hepatic encephalopathy defined as West-Haven score of 2 or more and spontaneous bacterial peritonitis; and death.
From Day 1 up to Week 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)
기간: TEAEs were collected from the start of study treatment administration (Day 1) up to DCO date of 01 June 2023, approximately 980 days.

An AE was any untoward medical occurrence in a participant or clinical investigation participant who was administered an investigational product, and which does not necessarily have a causal relationship with treatment. A TEAE was defined as any AE with onset during TEAE assessment period, or any event started prior to first dose of treatment and worsened or became serious during the TEAE assessment period. An SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect. An AESI was an AE that might not be serious but was of special importance to a particular treatment or class.
TEAEs were collected from the start of study treatment administration (Day 1) up to DCO date of 01 June 2023, approximately 980 days.
Plasma Concentrations of Elafibranor and GFT1007
기간: Week 4: pre-dose, 0.5 hour, 1.5 hours, between 2-3 hours, 4 hours and 6 hours post-dose

Blood samples were collected at specified timepoints to evaluate plasma concentration of Elafibranor and its metabolite GFT1007.
Week 4: pre-dose, 0.5 hour, 1.5 hours, between 2-3 hours, 4 hours and 6 hours post-dose

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스폰서

Ipsen

수사관

  • 연구 책임자: Ipsen Medical Director, Ipsen

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 9월 24일

기본 완료 (실제)

2023년 6월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2020년 8월 21일

QC 기준을 충족하는 최초 제출

2020년 8월 21일

처음 게시됨 (실제)

2020년 8월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 20일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GFT505B-319-1
  • 2019-004941-34 (EudraCT 번호)
  • 2019 (미국 NIH 보조금/계약)

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IPD 계획 설명

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

IPD 공유 기간

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

IPD 공유 액세스 기준

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

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미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

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구독하다