Uno studio per valutare la sicurezza e l'efficacia di Elafibranor nei partecipanti adulti con colangite sclerosante primitiva. (ELMWOOD)
20 ottobre 2026 aggiornato da: Ipsen
Uno studio di fase II, multicentrico, in doppio cieco, randomizzato, controllato con placebo ed estensione a lungo termine in aperto per valutare la sicurezza e l'efficacia di Elafibranor nei partecipanti adulti con colangite sclerosante primaria (PSC).
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional open-label extension long-term (OLE-LT) period beyond OLE Week 96. PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug, including long-term safety during the open-label extension periods. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.
Panoramica dello studio
Stato
Stato
Attivo, non reclutante
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
68
Fase
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Calgary, Canada, T3H 0V5
- Aspen Woods Clinic
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Montreal, Canada, H2X 0A9
- Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
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Vancouver, Canada, V6Z 2K5
- G.I Research Institute
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary
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Edmonton, Alberta, Canada, T6G 2X8
- University Of Alberta Hospital-Zeidler Ledcor Centre
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
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Berlin, Germania, 13353
- Charite Campus Virchow
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Frankfurt, Germania, 60590
- Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
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Heidelberg, Germania, 69120
- Universitaetsklinikum Heidelberg - Nationales Centrum fuer Tumorerkrankungen
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Ulm, Germania, 89081
- University Hospital Ulm
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Modena, Italia, 41124
- Azienda Ospedaliero Universitaria Modena
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Padova, Italia, 35128
- Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
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Palermo, Italia, 90127
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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Rozzano, Italia, 20089
- Gruppo Humanitas - Humanitas Research Hospital, Istituto Clinico Humanitas
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San Giovanni Rotondo, Italia, 71013
- Ospedale Casa Sollievo della Sofferenza
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Guimarães, Portogallo, 4800-055
- Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
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Lisbon, Portogallo, 1345-035
- Centro Hospitalar Universitario Lisboa Norte
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Lisbon, Portogallo, 1349-019
- Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
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Aberdeen, Regno Unito, AB25 2ZD
- Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
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Birmingham, Regno Unito, B15 2TT
- Queen Elizabeth Hospital
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Frimley, Regno Unito, GU16 7UJ
- Frimley Park Hospital - Frimley Health NHS Foundation Trust
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Glasgow, Regno Unito, G4 0SF
- Glasgow Royal Infirmary - Greater Glasgow Health Board
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Hull, Regno Unito, HU3 2JZ
- Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
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London, Regno Unito, NW3 2QG
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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London, Regno Unito, E1 1BB
- Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
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Barcelona, Spagna, 08035
- Hospital Universitario Vall d'Hebron
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Madrid, Spagna, 28046
- Hospital Universitario La Paz
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Madrid, Spagna, 28007
- Hospital General Universitario Gregorio Maranon (HGUGM)
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Majadahonda, Spagna, 28222
- Hospital Universitario Puerta de Hierro
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Pontevedra, Spagna, 36071
- Hospital De Montecelo
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Valladolid, Spagna, 47012
- Hospital Universitario Rio Hortega
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Zaragoza, Spagna, 50009
- Hospital Universitario Miguel Servet
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California
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Lancaster, California, Stati Uniti, 93534
- Om Research LLC
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Los Angeles, California, Stati Uniti, 90048
- Cedars-Sinai Medical Center
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Sacramento, California, Stati Uniti, 95817
- University of California, Davis
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San Francisco, California, Stati Uniti, 94109
- Sutter Health Van Ness Campus Medical Office Building
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80907
- Peak Gastroenterology Associates
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Englewood, Colorado, Stati Uniti, 80113
- South Denver Gastroenterology,P.C.
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Littleton, Colorado, Stati Uniti, 80120
- Rocky Mountain Gastroenterology (RMG)
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06510
- Yale University School Of Medicine - Yale Center For Clinical Investigation
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Florida
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Miami, Florida, Stati Uniti, 33136
- Schiff Center for Liver Diseases - University of Miami
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Sarasota, Florida, Stati Uniti, 34240
- Covenant Research
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Georgia
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Atlanta, Georgia, Stati Uniti, 30309
- Piedmont Hospital - Piedmont Transplant Institute
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Louisiana
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Marrero, Louisiana, Stati Uniti, 70072
- Tandem Clinical Research GI
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Maryland
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Baltimore, Maryland, Stati Uniti, 21202
- Mercy Medical Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Medical Center, Liver Research Center
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Michigan
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Ypsilanti, Michigan, Stati Uniti, 48197
- Huron Gastroenterology Associates - Center for Digestive Care
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68198
- University of Nebraska Medical Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87109-4342
- Southwest Gastroenterology Associates, PC (SWGA)
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New York
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New York, New York, Stati Uniti, 06510
- New York University Langone Health
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- Gastro Health Research
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State Milton S Hershey Medical Center
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Philadelphia, Pennsylvania, Stati Uniti, 19017
- Thomas Jefferson University
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Medical University of South Carolina
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Tennessee
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Cordova, Tennessee, Stati Uniti, 38018
- Gastro One
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Texas
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Dallas, Texas, Stati Uniti, 75235
- University Of Texas Southwestern Medical Center At Dallas
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San Antonio, Texas, Stati Uniti, 78215
- American Research Corporation at The Texas Liver Institute
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Utah
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Murray, Utah, Stati Uniti, 84107
- Intermountain Medical Center
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22093
- University of Virginia Medical Center
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Richmond, Virginia, Stati Uniti, 23298
- Virginia Commonwealth University
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Richmond, Virginia, Stati Uniti, 23226
- Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
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Washington
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Seattle, Washington, Stati Uniti, 98105
- Liver Institute Northwest
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria :
The following inclusion criteria apply to entry into the double-blind period and initial open-label extension (OLE) period up to OLE Week 96, unless otherwise specified.
- Participants with a diagnosis of Primary sclerosing cholangitis (PSC) as demonstrated by the presence of the following, and in the absence of apparent causes of secondary sclerosing cholangitis: i) Historical evidence of an elevated Alkaline phosphatase (ALP) > Upper Limit Normal (ULN) since at least 6 months prior to SV1. ii) Cholangiogram (e.g. magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC) with features compatible with large duct PSC.
- ALP ≥1.5x ULN during screening (with variability ≤30% based on two values).
- Total bilirubin ≤2.0x ULN at Screening Visit 1(SV1)
- Participants taking ursodeoxycholic acid (UDCA) at a total daily dose ≤23 mg/kg/day, with a minimum of 6 months of stable treatment prior to screening period and expected to remain on stable dose through the 12-week DBP. Minimum of 3 months off treatment prior to screening period if UDCA was recently discontinued.
- For participants with Inflammatory bowel disease (IBD): i) Participants with Crohn's disease must be in remission based on the investigator's clinical assessment and should be on stable treatment prior to randomisation and during screening. ii) Participants with ulcerative colitis must be in remission or have low activity disease as per the judgement of the investigator and should be on stable treatment prior to randomisation and during screening. iii) Current treatment for IBD is permitted, if the participant has been well controlled for ≥3 months prior to the screening period and is anticipated to remain on a stable dose of drugs for IBD treatment, including biologics, immunosuppressants, immunomodulators, or systemic corticosteroids. iv) Participants with IBD should have a colonoscopy performed within one year prior to the screening period showing no evidence of dysplasia or cancer.
- Medications for management of pruritus (e.g. cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for ≥3 months prior to the screening period.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -A female participant is eligible to participate if she is not pregnant or breastfeeding at screening, is willing not to become pregnant during the study and is willing to follow applicable protocol requirements related to this. - Male participants are eligible to participate if they agree to follow applicable protocol requirements related to contraception.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Inclusion Criteria for Entry into Optional Open-Label Extension Long-Term (OLE-LT) Period Beyond Week 96
For entry into the optional OLE-LT period, participants:
- Must have completed the initial OLE period up to OLE Week 96
- Must not have permanently discontinued the study intervention during the initial OLE period
- Must, in the opinion of the investigator, benefit from continuing to receive study intervention The eligibility criteria assessed at Screening Visit 1 (SV1) for entry into the double-blind period are not reassessed for entry into the optional OLE-LT period.
Contraception requirements applicable during the OLE-LT period:
- Male participants: No contraception requirements apply.
- Female participants of childbearing potential: Must continue to use a highly effective contraceptive method during study intervention and for at least one month after the last dose. If using a hormonal contraceptive, an additional barrier method or a switch to a highly effective non-hormonal method is required.
Exclusion Criteria :
- History or presence of other concomitant chronic liver disease including: i) ImmunoglobulinG 4 (IgG4) related sclerosing cholangitis, or IgG4 ≥4x ULN at SV1. ii) Small duct PSC. iii) Documented history of secondary sclerosing cholangitis. iv) Presence of hepatitis B surface antigen (HBsAg) at screening. v) Hepatitis C virus (HCV) infection vi) Primary biliary cholangitis (PBC) or positive anti-mitochondrial antibody. vii) Alcohol-related liver disease. viii) Autoimmune hepatitis (AIH): Simplified Diagnostic Criteria of the IAIHG ≥6. ix) Presence of history of PSC-PBC or PSC-AIH overlap syndrome. x) Non-alcoholic steatohepatitis (NASH). SMD form protocol master data--23- INT / Version 1 Known history of alpha-1 antitrypsin deficiency
- Presence of percutaneous drain or bile duct stent at screening or within three months prior to screening.
- History of bacterial cholangitis within 60 days prior to the screening period, or participant on antibiotics for prophylaxis of recurrent cholangitis.
- History or any current suspicion of cholangiocarcinoma or elevated value of carbohydrate antigen 19-9 (CA19-9) >129 U/mL at SV1.
- Alpha-fetoprotein (AFP) >20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) suggesting presence of liver cancer.
- Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child-Pugh score. Participants with cirrhosis with Child-Pugh A score are allowed.
- History of clinically significant hepatic decompensation as described in the study protocol
- Presence or history of hepatocellular carcinoma.
- Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
- Medical conditions that may diminish life expectancy to <2 years, including known cancers.
- Participant has a positive test for human immunodeficiency virus (HIV) type 1 or 2 at SV1, or participant is known to have tested positive for HIV.
- Evidence of any other unstable or untreated clinically significant immunological, endocrine, neurological, gastrointestinal, haematologic, psychiatric diseases as evaluated by the investigator; other clinically significant conditions that are not well controlled
- Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
- Participants with previous exposure to elafibranor
- ALT and/or AST >5x ULN
- Albumin <3.0 g/dL at SV1.
- Platelet count <100,000/microliter.
- International normalised ratio (INR) >1.3 due to altered hepatic function.
- Creatine phosphokinase (CPK) >2x ULN during screening period.
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
5
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Double-Blind Period: Elafibranor 80 mg
Participant will receive two tablets per day (one tablet of elafibranor 80 mg + 1 tablet of placebo matching the 120 mg sized tablet) over the 12 weeks in Double-blind period. |
Oral Tablet
Altri nomi:
Oral Tablet |
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Sperimentale: Double-Blind Period: Elafibranor 120 mg
Participant will receive 2 tablets per day (one tablet of elafibranor 120 mg + 1 tablet of placebo matching the 80 mg sized tablet) over the 12 weeks in Double-blind period. |
Oral Tablet
Altri nomi:
Oral Tablet |
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Comparatore placebo: Double-Blind Period: Placebo
Participant will receive 2 placebo tablets per day (one matching the 80 mg sized tablet + one matching the 120 mg sized tablet) over the 12 weeks in Double-blind period. |
Oral Tablet |
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Sperimentale: Initial Open-Label Extension (OLE) Period up to OLE Week 96: Elafibranor 120 mg
Participant will receive one tablet per day (elafibranor 120 mg) during the initial 96-weeks Open-Label extension period. |
Oral Tablet
Altri nomi:
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Sperimentale: Open-Label Extension Long-Term (OLE-LT) Period Beyond OLE Week 96: Elafibranor 120 mg
Participant will receive one tablet per day (elafibranor 120 mg) during the optional Open-Label Extension Long-Term period beyond OLE Week 96 |
Oral Tablet
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Lasso di tempo: Double Blind Period: Baseline up to week 12, Initial Open Label Extension (OLE) Period: Baseline up to week 100, Open-Label Extension Long-Term (OLE-LT) Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs. |
Double Blind Period: Baseline up to week 12, Initial Open Label Extension (OLE) Period: Baseline up to week 100, Open-Label Extension Long-Term (OLE-LT) Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Lasso di tempo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator. |
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Lasso di tempo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator. |
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Percentage of Participants With Clinically Significant Changes in Vital Signs
Lasso di tempo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator. |
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings
Lasso di tempo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator. |
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentuale di partecipanti con ALP:
Lasso di tempo: Periodo in doppio cieco: settimana 12
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Periodo in doppio cieco: settimana 12
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Percentuale di partecipanti che hanno normalizzato l'ALP
Lasso di tempo: Periodo in doppio cieco: settimana 12
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Periodo in doppio cieco: settimana 12
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Variazione rispetto al basale dei livelli di albumina alla settimana 12
Lasso di tempo: Basale, settimana 12
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Basale, settimana 12
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Variazione rispetto al basale nel punteggio del test della fibrosi epatica potenziata (ELF).
Lasso di tempo: Periodo in doppio cieco: basale, settimana 12
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Periodo in doppio cieco: basale, settimana 12
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Variazione rispetto al basale nei valori di misurazione della rigidità epatica (LSM) valutati da FibroScan® alla settimana 12
Lasso di tempo: Periodo in doppio cieco: basale, settimana 12
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Periodo in doppio cieco: basale, settimana 12
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Variazione rispetto al basale in altri marcatori sierici di fibrosi epatica non invasiva misurati da PAI-1, TGF-β, marcatore di formazione di collagene di tipo V (Pro-C5) e marcatore di formazione di collagene di tipo III (Pro-C3)
Lasso di tempo: Periodo in doppio cieco: basale, settimana 12
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Periodo in doppio cieco: basale, settimana 12
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Variazione rispetto al basale della fibrosi-4 (FIB-4) e dell'indice del rapporto tra AST e piastrine (APRI)
Lasso di tempo: Periodo in doppio cieco: basale, settimana 12
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Periodo in doppio cieco: basale, settimana 12
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Variazione rispetto al basale dei livelli di citocheratina-18 (CK-18) (M65 e M30)
Lasso di tempo: Periodo in doppio cieco: basale, settimana 12
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Periodo in doppio cieco: basale, settimana 12
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PK di Elafibranor e del suo metabolita GFT1007: massima (picco) concentrazione plasmatica del farmaco osservata (Cmax)
Lasso di tempo: Pre-dose, 0,5 ore (h), 1 ora, tra 1,5 ore e 2 ore, 4 ore e 6 ore dopo la somministrazione alla settimana 4
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Pre-dose, 0,5 ore (h), 1 ora, tra 1,5 ore e 2 ore, 4 ore e 6 ore dopo la somministrazione alla settimana 4
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Relative Change From Baseline in Alkaline Phosphatase Levels (ALP)
Lasso di tempo: Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96, OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96, OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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Percentage of Participants With ≥40% Decrease from Baseline in ALP Levels
Lasso di tempo: Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
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Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
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Absolute Change from Baseline in ALP
Lasso di tempo: Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
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Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
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Change From Baseline in Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma-glutamyl transferase (GGT) Levels
Lasso di tempo: Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
|
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Change From Baseline in 5' Nucleotidase and Fractionated ALP Levels at Week 12
Lasso di tempo: Baseline, Week 12
|
Baseline, Week 12
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Change From Baseline in Total bilirubin Levels
Lasso di tempo: Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
|
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Change From Baseline in Conjugated bilirubin Levels at Week 12
Lasso di tempo: Baseline, Week 12
|
Baseline, Week 12
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Number and Percentage of Participants With Clinical Outcome Events During the OLE-LT Period
Lasso di tempo: Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
|
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Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUC0-24)
Lasso di tempo: Pre-dose, 0.5 hour (h), 1h, between 1.5 hours and 2h, 4h, and 6h after dosing at Week 4
|
AUC 0-24 will be recorded from the PK blood samples collected. |
Pre-dose, 0.5 hour (h), 1h, between 1.5 hours and 2h, 4h, and 6h after dosing at Week 4
|
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PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
Lasso di tempo: Pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at Week 4
|
Tmax will be recorded from the PK blood samples collected. |
Pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at Week 4
|
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PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
Lasso di tempo: Double Blind Period: Baseline up to Week 12
|
Cl/F will be recorded from the PK blood samples collected. |
Double Blind Period: Baseline up to Week 12
|
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PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vz)
Lasso di tempo: Double Blind Period: Baseline up to Week 12
|
Vz will be recorded from the PK blood samples collected. |
Double Blind Period: Baseline up to Week 12
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Ipsen Medical, Director, Ipsen
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
29 dicembre 2022
Completamento primario (Stimato)
Completamento primario
23 settembre 2031
Completamento dello studio (Stimato)
Completamento dello studio
23 settembre 2031
Date di iscrizione allo studio
Primo inviato
Primo inviato
22 novembre 2022
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
23 novembre 2022
Primo Inserito (Effettivo)
Primo Inserito
25 novembre 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
23 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 ottobre 2026
Ultimo verificato
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- CLIN-60190-453
- 2022-002695-37 (Numero EudraCT)
- 2024-511370-72-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .