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原発性硬化性胆管炎の成人参加者におけるエラフィブラノールの安全性と有効性を評価するための研究。 (ELMWOOD)

2026年10月20日 更新者：Ipsen

原発性硬化性胆管炎（PSC）の成人参加者におけるエラフィブラノールの安全性と有効性を評価するための第II相、多施設共同、二重盲検、無作為化、プラセボ対照試験および非盲検長期延長。

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

68

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Lancaster、California、アメリカ、93534
        • Om Research LLC
      • Los Angeles、California、アメリカ、90048
        • Cedars-Sinai Medical Center
      • Sacramento、California、アメリカ、95817
        • University of California, Davis
      • San Francisco、California、アメリカ、94109
        • Sutter Health Van Ness Campus Medical Office Building
    • Colorado
      • Colorado Springs、Colorado、アメリカ、80907
        • Peak Gastroenterology Associates
      • Englewood、Colorado、アメリカ、80113
        • South Denver Gastroenterology,P.C.
      • Littleton、Colorado、アメリカ、80120
        • Rocky Mountain Gastroenterology (RMG)
    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • Yale University School Of Medicine - Yale Center For Clinical Investigation
    • Florida
      • Miami、Florida、アメリカ、33136
        • Schiff Center for Liver Diseases - University of Miami
      • Sarasota、Florida、アメリカ、34240
        • Covenant Research
    • Georgia
      • Atlanta、Georgia、アメリカ、30309
        • Piedmont Hospital - Piedmont Transplant Institute
    • Louisiana
      • Marrero、Louisiana、アメリカ、70072
        • Tandem Clinical Research GI
    • Maryland
      • Baltimore、Maryland、アメリカ、21202
        • Mercy Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • Beth Israel Deaconess Medical Center, Liver Research Center
    • Michigan
      • Ypsilanti、Michigan、アメリカ、48197
        • Huron Gastroenterology Associates - Center for Digestive Care
    • Nebraska
      • Omaha、Nebraska、アメリカ、68198
        • University of Nebraska Medical Center
    • New Mexico
      • Albuquerque、New Mexico、アメリカ、87109-4342
        • Southwest Gastroenterology Associates, PC (SWGA)
    • New York
      • New York、New York、アメリカ、06510
        • New York University Langone Health
    • Ohio
      • Cincinnati、Ohio、アメリカ、45219
        • Gastro Health Research
    • Pennsylvania
      • Hershey、Pennsylvania、アメリカ、17033
        • Penn State Milton S Hershey Medical Center
      • Philadelphia、Pennsylvania、アメリカ、19017
        • Thomas Jefferson University
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • Medical University of South Carolina
    • Tennessee
      • Cordova、Tennessee、アメリカ、38018
        • Gastro One
    • Texas
      • Dallas、Texas、アメリカ、75235
        • University Of Texas Southwestern Medical Center At Dallas
      • San Antonio、Texas、アメリカ、78215
        • American Research Corporation at The Texas Liver Institute
    • Utah
      • Murray、Utah、アメリカ、84107
        • Intermountain Medical Center
    • Virginia
      • Charlottesville、Virginia、アメリカ、22093
        • University of Virginia Medical Center
      • Richmond、Virginia、アメリカ、23298
        • Virginia Commonwealth University
      • Richmond、Virginia、アメリカ、23226
        • Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
    • Washington
      • Seattle、Washington、アメリカ、98105
        • Liver Institute Northwest
  • イギリス
      • Aberdeen、イギリス、AB25 2ZD
        • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
      • Birmingham、イギリス、B15 2TT
        • Queen Elizabeth Hospital
      • Frimley、イギリス、GU16 7UJ
        • Frimley Park Hospital - Frimley Health NHS Foundation Trust
      • Glasgow、イギリス、G4 0SF
        • Glasgow Royal Infirmary - Greater Glasgow Health Board
      • Hull、イギリス、HU3 2JZ
        • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
      • London、イギリス、NW3 2QG
        • The Royal Free Hospital - Royal Free London NHS Foundation Trust
      • London、イギリス、E1 1BB
        • Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
  • イタリア
      • Modena、イタリア、41124
        • Azienda Ospedaliero Universitaria Modena
      • Padova、イタリア、35128
        • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
      • Palermo、イタリア、90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
      • Rozzano、イタリア、20089
        • Gruppo Humanitas - Humanitas Research Hospital, Istituto Clinico Humanitas
      • San Giovanni Rotondo、イタリア、71013
        • Ospedale Casa Sollievo della Sofferenza
  • カナダ
      • Calgary、カナダ、T3H 0V5
        • Aspen Woods Clinic
      • Montreal、カナダ、H2X 0A9
        • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
      • Vancouver、カナダ、V6Z 2K5
        • G.I Research Institute
    • Alberta
      • Calgary、Alberta、カナダ、T2N 4Z6
        • University of Calgary
      • Edmonton、Alberta、カナダ、T6G 2X8
        • University Of Alberta Hospital-Zeidler Ledcor Centre
    • Ontario
      • Brampton、Ontario、カナダ、L6R 3J7
        • Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
  • スペイン
      • Barcelona、スペイン、08035
        • Hospital Universitario Vall d'Hebron
      • Madrid、スペイン、28046
        • Hospital Universitario La Paz
      • Madrid、スペイン、28007
        • Hospital General Universitario Gregorio Maranon (HGUGM)
      • Majadahonda、スペイン、28222
        • Hospital Universitario Puerta de Hierro
      • Pontevedra、スペイン、36071
        • Hospital De Montecelo
      • Valladolid、スペイン、47012
        • Hospital Universitario Rio Hortega
      • Zaragoza、スペイン、50009
        • Hospital Universitario Miguel Servet
  • ドイツ
      • Berlin、ドイツ、13353
        • Charite Campus Virchow
      • Frankfurt、ドイツ、60590
        • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
      • Heidelberg、ドイツ、69120
        • Universitaetsklinikum Heidelberg - Nationales Centrum fuer Tumorerkrankungen
      • Ulm、ドイツ、89081
        • University Hospital Ulm
  • ポルトガル
      • Guimarães、ポルトガル、4800-055
        • Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
      • Lisbon、ポルトガル、1345-035
        • Centro Hospitalar Universitario Lisboa Norte
      • Lisbon、ポルトガル、1349-019
        • Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Elafibranor 80 mg

Oral Tablet

他の名前：
  • GFT505
薬：Placebo Matched to Elafibranor 120 mg

Oral Tablet
実験的：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.
薬：Elafibranor 120 mg

Oral Tablet

他の名前：
  • GFT505
薬：Placebo Matched to Elafibranor 80 mg

Oral Tablet
プラセボコンパレーター：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.
薬：Placebo Matched to Elafibranor 80 mg

Oral Tablet
実験的：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.
薬：Elafibranor 120 mg

Oral Tablet

他の名前：
  • GFT505
実験的：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
薬：Elafibranor 120 mg

Oral Tablet

他の名前：
  • GFT505

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
時間枠：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

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
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
時間枠：Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

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
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
時間枠：Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

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
Percentage of Participants With Clinically Significant Changes in Vital Signs
時間枠：Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

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
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings
時間枠：Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

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

二次結果の測定

結果測定
メジャーの説明
時間枠
ALPの参加者の割合:
時間枠：二重盲検期：12週目
二重盲検期：12週目
ALPを正常化した参加者の割合
時間枠：二重盲検期：12週目
二重盲検期：12週目
12週目のアルブミンレベルのベースラインからの変化
時間枠：ベースライン、12週目
ベースライン、12週目
強化肝線維症（ELF）検査スコアのベースラインからの変化
時間枠：二重盲検期間: ベースライン、12 週目
二重盲検期間: ベースライン、12 週目
12週目にFibroScan®によって評価された肝臓剛性測定（LSM）値のベースラインからの変化
時間枠：二重盲検期間: ベースライン、12 週目
二重盲検期間: ベースライン、12 週目
PAI-1、TGF-β、V 型コラーゲン形成のマーカー (Pro-C5)、および III 型コラーゲン形成のマーカー (Pro-C3) によって測定される他の非侵襲性肝線維症血清マーカーのベースラインからの変化
時間枠：二重盲検期間: ベースライン、12 週目
二重盲検期間: ベースライン、12 週目
線維症-4 (FIB-4) および AST から血小板比指数 (APRI) へのベースラインからの変化
時間枠：二重盲検期間: ベースライン、12 週目
二重盲検期間: ベースライン、12 週目
サイトケラチン-18 (CK-18) (M65 および M30) レベルのベースラインからの変化
時間枠：二重盲検期間: ベースライン、12 週目
二重盲検期間: ベースライン、12 週目
Elafibranor およびその代謝物 GFT1007 の PK: 最大 (ピーク) 観察された血漿薬物濃度 (Cmax)
時間枠：投与前、0.5 時間 (h)、1 時間、4 週目の投与後 1.5 時間から 2 時間、4 時間、および 6 時間後
投与前、0.5 時間 (h)、1 時間、4 週目の投与後 1.5 時間から 2 時間、4 時間、および 6 時間後
Relative Change From Baseline in Alkaline Phosphatase Levels (ALP)
時間枠：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
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
Percentage of Participants With ≥40% Decrease from Baseline in ALP Levels
時間枠：Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Absolute Change from Baseline in ALP
時間枠：Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Change From Baseline in Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma-glutamyl transferase (GGT) Levels
時間枠：Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Change From Baseline in 5' Nucleotidase and Fractionated ALP Levels at Week 12
時間枠：Baseline, Week 12
Baseline, Week 12
Change From Baseline in Total bilirubin Levels
時間枠：Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Change From Baseline in Conjugated bilirubin Levels at Week 12
時間枠：Baseline, Week 12
Baseline, Week 12
Number and Percentage of Participants With Clinical Outcome Events During the OLE-LT Period
時間枠：Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
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)
時間枠：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
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
時間枠：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
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
時間枠：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
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vz)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ipsen

捜査官

  • スタディディレクター：Ipsen Medical, Director、Ipsen

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年12月29日

一次修了 (推定)

2031年9月23日

研究の完了 (推定)

2031年9月23日

試験登録日

最初に提出

2022年11月22日

QC基準を満たした最初の提出物

2022年11月23日

最初の投稿 (実際)

2022年11月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月23日

QC基準を満たした最後の更新が送信されました

2026年10月20日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CLIN-60190-453
  • 2022-002695-37 (EudraCT番号)
  • 2024-511370-72-00 (Ctis)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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