이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

관찰 연구 프로토콜: LIVER-R (LIVER-R)

2026년 10월 27일 업데이트: AstraZeneca

간담도암에 대한 Durvalumab 기반 요법의 실제 치료 결과를 평가하기 위한 관찰 다기관 연구

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of regimens (durvalumab-based or otherwise) in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence ).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

LIVER-R is a real-world, multi-country, multi-centre study aiming to enroll approximately 4,000 patients across hepatobiliary cohorts (approximately 1,385 patients for aBTC, approximately 1,165 patients for uHCC, approximately 1,000 patients for eeHCC, and approximately 400 patients for EMERALD) across multiple countries from North and South America, Europe, the Middle East and the Asia-Pacific region. The study design will include primary and secondary data collection. Primary data will be collected in real-time during the patient's routine visit. Secondary data will be collected from the patient's medical record at enrollment and at prespecified study time points (6-month intervals). The study population includes adult patients whose physician has previously made the decision to treat them with or without a durvalumab-based regimen for hepatobiliary cancer as part of routine clinical practice or patients receiving treatment through EAP. The study will include a baseline period of up to 5 years before the index date (initiation of a durvalumab-based or non durvalumab-based regimen) and a follow-up period to the earliest of death, loss to follow-up, withdrawal, or end of study for a minimum follow-up of 2 years. This is a descriptive, noncomparative study. No formal hypotheses are to be tested. All descriptive analyses will be conducted separately for each primary hepatobiliary cancer indication. Kaplan Meier estimates will be produced for time-to-event outcomes.

연구 유형

관찰

등록 (추정된)

4000

연락처 및 위치

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

연구 연락처

연구 장소

  • 그리스
    • Athens
      • Chaïdári, Athens, 그리스, 12462
        • 모병
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    • Attica
      • Athens, Attica, 그리스, 11527
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      • Athens, Attica, 그리스, 14564
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    • Central Macedonia
      • Thessaloniki, Central Macedonia, 그리스, 55236
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      • Thessaloniki, Central Macedonia, 그리스, 54639
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    • Thessaly
      • Larissa, Thessaly, 그리스, 41110
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  • 노르웨이
    • Akershus
      • Lorenskog, Akershus, 노르웨이, 1478
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    • Hordaland
      • Bergen, Hordaland, 노르웨이, 5021
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      • Konstanz, Baden-W Rttemberg, 독일, 78484
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      • Augsburg, Bavaria, 독일, 86150
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    • Free Hanseatic City of Bremen
      • Bremenhaven, Free Hanseatic City of Bremen, 독일, 27574
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      • Kassel, Hesse, 독일, 34125
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      • Göttingen, Lower Saxony, 독일, 37075
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      • Dresden, Saxony, 독일, 1307
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    • Florida
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    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70808
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    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
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    • Missouri
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      • White Plains, New York, 미국, 10601
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      • Canton, Ohio, 미국, 44718
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    • Pennsylvania
      • Bethlehem, Pennsylvania, 미국, 18015
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      • Lancaster, Pennsylvania, 미국, 17604
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      • Philadelphia, Pennsylvania, 미국, 19141
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    • Texas
      • Dallas, Texas, 미국, 75390-8567
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      • Temple, Texas, 미국, 76508
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    • Washington
      • Spokane, Washington, 미국, 99204
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  • 벨기에
    • Anderlecht
      • Brussels, Anderlecht, 벨기에, 1070
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    • Antwerp
      • Bonheiden, Antwerp, 벨기에, 2820
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      • Edegem, Antwerp, 벨기에, 2650
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    • Brabant
      • Leuven, Brabant, 벨기에, 3000
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    • Wallonia
      • Liège, Wallonia, 벨기에, 4000
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    • West Flanders
      • Stene, West Flanders, 벨기에, 8400
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  • 브라질
      • São Paulo, 브라질, 04538-132
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      • São Paulo, 브라질, 01246-000
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    • Paraná
      • Curitiba, Paraná, 브라질, 81480-580
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    • Recife - PE
      • Recife - PE, Recife - PE, 브라질, 50070-490
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    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, 브라질, 90035-001
        • 모병
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    • São Paulo
      • Morumbi, São Paulo, 브라질, 05651-901
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  • 사우디 아라비아
    • Ar Riyadh
      • Riyadh, Ar Riyadh, 사우디 아라비아, 12231
        • 모병
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    • Mecca Region
      • Jeddah, Mecca Region, 사우디 아라비아, 22384
        • 모병
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  • 스위스
      • Zurich, 스위스, 8032
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    • Canton of Vaud
      • Lausanne, Canton of Vaud, 스위스, 1005
        • 모병
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  • 스페인
      • Barcelona, 스페인, 8035
        • 모병
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      • Madrid, 스페인, 28007
        • 모병
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      • Madrid, 스페인, 28034
        • 모병
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      • Madrid, 스페인, 28040
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      • Madrid, 스페인, 28041
        • 모병
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      • Oviedo, 스페인, 33011
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      • Pamplona, 스페인, 31008
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      • Santa Cruz de Tenerife, 스페인, 38010
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      • Seville, 스페인, 41009
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      • Valencia, 스페인, 46010
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    • A Coru A
      • Santiago de Compostela, A Coru A, 스페인, 15706
        • 모병
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    • Aragon
      • Zaragoza, Aragon, 스페인, 50009
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    • C Rdoba
      • Poniente Sur, C Rdoba, 스페인, 14004
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    • Cantabria
      • Santander, Cantabria, 스페인, 39008
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      • Burgos, Castile-Le N, 스페인, 9006
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    • Galicia
      • Ourense, Galicia, 스페인, 32005
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    • Madrid
      • Majadahonda, Madrid, 스페인, 28222
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    • Murcia
      • El Palmar, Murcia, 스페인, 30120
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  • 싱가포르
      • Singapore, 싱가포르, 169610
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      • Singapore, 싱가포르, 329563
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      • Mohammed Bin Zayed City, Abu Dhabi Emirate, 아랍 에미리트, 92510
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      • Sankt Pölten, Lower Austria, 오스트리아, 3100
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      • Linz, Upper Austria, 오스트리아, 4010
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  • 이스라엘
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      • Brescia, Lombardy, 이탈리아, 25123
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      • Turin, Piedmont, 이탈리아, 10126
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    • Aichi-ken
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      • Kashiwa-shi, Chiba, 일본, 277-8577
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      • Kurume, Fukuoka, 일본, 830-0011
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      • Kanazawa, Ishikawa-ken, 일본, 920-8641
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      • Yokohama, Kanagawa, 일본, 241-8515
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      • Kyoto, Kyoto, 일본, 606-8507
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      • Sendai, Miyagi, 일본, 980-8574
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    • Osaka
      • Ōsaka-sayama, Osaka, 일본, 589-8511
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    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4N2
        • 모병
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      • Edmonton, Alberta, 캐나다, T6G-1Z2
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    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3H 2Y9
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    • Ontario
      • London, Ontario, 캐나다, N6A 5W9
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  • 포르투갈
      • Faro, 포르투갈, 8000-386
        • 모병
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      • Lisbon, 포르투갈, 1400 - 038
        • 모병
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      • Lisbon, 포르투갈, 1649-028
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    • North
      • Vila Real, North, 포르투갈, 5000-508
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    • Rio Piedras
      • San Juan, Rio Piedras, 푸에르토 리코, 00935
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    • Alsace
      • Strasbourg, Alsace, 프랑스, 67000
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      • Grenoble, Auvergne-Rh ne-Alpes, 프랑스, 38700
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    • Brittany Region
      • St-Malo, Brittany Region, 프랑스, 35403
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    • Grand Est
      • Mulhouse, Grand Est, 프랑스, 68100
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    • Hauts-de-France
      • Boulogne-sur-Mer, Hauts-de-France, 프랑스, 62200
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    • New Aquitaine
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    • Île-de-France Region
      • Paris, Île-de-France Region, 프랑스, 75012
        • 모병
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      • Paris, Île-de-France Region, 프랑스, 75014
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  • 호주
    • Australian Capital Territory
      • Garran, Australian Capital Territory, 호주, 2605
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    • Victoria
      • Heidelberg, Victoria, 호주, 3084
        • 모병
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      • Melbourne, Victoria, 호주, 3004
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    • Western Australia
      • Murdoch, Western Australia, 호주, 6150
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비확률 샘플

연구 인구

The study population includes patients treated with durvalumab-based and non durvalumab-based regimens for hepatobiliary cancer as part of routine clinical practice. The decision to treat patients with a durvalumab based regimen should be independent from the decision to enroll patients in the study.

설명

Inclusion Criteria General Inclusion Criteria

All patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below:

  1. Age ≥18 years and a lawful adult in the country at the index date
  2. Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)
  3. Decision to treat was made independently and prior to obtaining informed consent
  4. Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved)

aBTC Specific Inclusion Criteria

A patient will be eligible to be included in the aBTC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. Patient has unresectable aBTC
  2. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)

uHCC Specific Inclusion Criteria

A patient will be eligible to be included in the uHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. Patient has unresectable uHCC
  2. Not eligible for LRT, as well as for those who progressed following LRT
  3. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)

eeHCC Specific Inclusion Criteria

A patient will be eligible to be included in the eeHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. HCC confirmed by radiological or histological diagnosis
  2. Child-Pugh A-B7
  3. Disease not amenable to curative treatment but amenable to LRT at index
  4. Patients with liver-confined HCC who initiated first non-curative intent LRT on or after 01 January 2024
  5. Patients eligible for LRT with palliative intent such as TACE/ TARE/transarterial infusion chemotherapy (TAIC)/ hepatic arterial infusion chemotherapy (HAIC)/transarterial embolization (TAE) given by itself or in combination with other systemic therapy (can include durvalumab) within 60 days of the LRT

EMERALD Specific Inclusion Criteria

A patient will be eligible to be included in the EMERALD cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. HCC confirmed by radiological or histological diagnosis
  2. Child-Pugh score of A-B7
  3. Liver-confined disease not amenable to curative treatment but amenable to LRT at index
  4. Receipt of a durvalumab-based regimen in combination with LRT administered within 28 days of each other (index is the first of the two treatments administered)

Exclusion Criteria

General Exclusion Criteria

A patient will be excluded from participating in this study if they meet any of the following general criteria 1-2 or any cohort specific exclusion criteria:

  1. Currently/was participating or plans to participate in any clinical trial for investigational treatment for hepatobiliary cancers on or after the diagnosis date until the index date
  2. Second primary malignancy prior to HCC or BTC diagnosis

aBTC Specific Exclusion Criteria

A patient will be excluded from participating in the aBTC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Received a liver transplant during the baseline period
  2. Received more than 1 cycle of Gemcitabine + Cisplatin for biliary tract cancer on or after diagnosis of unresectable, locally advanced or metastatic disease through the index date. Patients who received any systemic therapy while having early stage, resectable disease are eligible

uHCC Specific Exclusion Criteria

A patient will be excluded from participating in the uHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Received a liver transplant during the baseline period
  2. Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date

eeHCC Specific Exclusion Criteria

A patient will be excluded from participating in the eeHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Eligible for curative therapy at the time of receiving LRT (ablation)
  2. Extrahepatic spread
  3. Portal vein tumor thrombosis (PVTT) of VP3/4
  4. Receipt of systemic therapy prior to index LRT in the baseline period
  5. Liver transplant any time prior to index

EMERALD Specific Exclusion Criteria

A patient will be excluded from participating in the EMERALD cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Eligible for curative therapy at the time of receiving LRT (ablation)
  2. Extrahepatic spread
  3. Portal vein tumor thrombosis (PVTT) of VP3/4
  4. Receipt of systemic therapy prior to index LRT in the baseline period
  5. Liver transplant any time prior to index

공부 계획

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연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: OTHER

코호트 및 개입

그룹/코호트
개입 / 치료
unresectable hepatocellular carcinoma (uHCC)

advanced uHCC patients who had not received prior systemic therapy and were not eligible for LRT, as well as those who had progressed following LRT, and who have received a durvalumab-based regimen
다른: Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

다른 이름들:
  • 임핀지
다른: Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

다른 이름들:
  • 임핀지
advanced biliary tract cancer (aBTC)

patients with advanced BTC (aBTC) who are not eligible for resection and who have received a durvalumab-based regimen
다른: Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

다른 이름들:
  • 임핀지
다른: Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

다른 이름들:
  • 임핀지
eeHCC

uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive LRT alone or LRT followed by systemic therapy within 60 days (if administered in combination, LRT must be received first)
다른: Non Durvalumab-based therapies in observational study setting

Data on patients who initiated non durvalumab-based regimens, including LRT alone or LRT followed by systemic therapies, will be collected.
EMERALD

uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive durvalumab-based regimens in combination with LRT (durvalumab and LRT are given within 28 days of each other, regardless of order)
다른: Durvalumab-based combination therapies in observational study settings

Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected

다른 이름들:
  • 임핀지

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Real-world overall survival (rwOS) in all participants
기간: rwOS will be assessed as OS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median OS for a minimum follow-up of 2 years.

rwOS will be calculated as the time from the index date to date of death, by any cause.
rwOS will be assessed as OS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median OS for a minimum follow-up of 2 years.

2차 결과 측정

결과 측정
측정값 설명
기간
Clinically significant events (CSEs) of interest leading to a medical intervention in all participants
기간: CSEs will be captured from the index date through 90 days after the last administration of durvalumab-based or non durvalumab-based regimens or death, whichever occurs first.

CSEs of interest leading to medical intervention including treatment interruption, discontinuation, hospitalization, or which require interventions of concomitant use of corticosteroids, immunosuppressants and/or endocrine therapies will be captured for the enrolled patients.
CSEs will be captured from the index date through 90 days after the last administration of durvalumab-based or non durvalumab-based regimens or death, whichever occurs first.
Patient demographic and clinical characteristics in all participants
기간: Patient demographic and clinical characteristics will be captured up to 5 years prior to the index date.

Descriptive statistics will be used to describe demographic and clinical characteristics for the enrolled patients.
Patient demographic and clinical characteristics will be captured up to 5 years prior to the index date.
Characterize the durvalumab-based regimen and/or LRT treatment patterns in all participants
기간: Treatment patterns will be captured from the index date until the earliest of death, loss to follow-up, withdrawal, or end of study for a minimum follow-up of 2 years.

Treatment patterns of the index durvalumab-based regimen or LRT will be described.

Treatment patterns of therapies administered both before and after the first administration of index durvalumab-based regimen or LRT will be described.
Treatment patterns will be captured from the index date until the earliest of death, loss to follow-up, withdrawal, or end of study for a minimum follow-up of 2 years.
Real-world duration of treatment (rwDOT) in all participants
기간: rwDOT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median DOT for a minimum follow-up of 2 years.

rwDOT will be calculated as the time from the index date to date of discontinuation of the index durvalumab-based regimen or LRT.
rwDOT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median DOT for a minimum follow-up of 2 years.
Real-world progression free survival (rwPFS) in all participants
기간: rwPFS will be assessed as PFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median PFS for a minimum follow-up of 2 years.

rwPFS will be calculated as the time from the index date to the earliest date of documented disease progression as determined by the physician's assessment or death.
rwPFS will be assessed as PFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median PFS for a minimum follow-up of 2 years.
Real-world time to progression (rwTTP) in all participants
기간: rwTTP will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTP for a minimum follow up of 2 years.

rwTTP will be calculated as the time from the index date to the date of documented disease progression as determined by the physician's assessment.
rwTTP will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTP for a minimum follow up of 2 years.
Real-world time to next treatment (rwTTNT) in all participants
기간: rwTTNT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTNT for a minimum follow-up of 2 years.

rwTTNT will be calculated as the time from the index date (first-line treatment date) to the date of initiation of the next treatment. rwTTNT will also be assessed for subsequent lines of therapy among patients who started a second line of therapy until a third line of therapy, patients who started a third line of therapy until a fourth line of therapy (rwTTNT), etc.
rwTTNT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTNT for a minimum follow-up of 2 years.
Real-world time to treatment discontinuation (rwTTD) in all participants
기간: rwTTD will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTD for a minimum follow-up of 2 years.

rwTTD will be calculated as the time from index date until discontinuation of treatment for any reason, including disease progression, toxicity, and death.
rwTTD will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTD for a minimum follow-up of 2 years.
Characterization of providers among all participants
기간: Provider characteristics will be captured up to 5 years prior to the index date

Descriptive statistics will be used to describe provider characteristics: academic vs. community.
Provider characteristics will be captured up to 5 years prior to the index date
Real-world recurrence free survival (rwRFS) in aBTC and uHCC
기간: rwRFS will be assessed as RFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median RFS for a minimum follow-up of 2 years.

rwRFS will be defined as the time from the index date to the earliest date of documented disease recurrence as determined by the physician's assessment or death, whichever is earlier. The analysis will be performed in patients who underwent curative therapy (resection or ablation).
rwRFS will be assessed as RFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median RFS for a minimum follow-up of 2 years.
Real-world time to recurrence (rwTTR) in aBTC and uHCC
기간: rwTTR will be assessed as recurrence rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTR for a minimum follow-up of 2 years.

rwTTR will be defined as the time from the index date to the date of documented disease recurrence as determined by the physician's assessment. The analysis will be performed in patients who underwent curative therapy (resection or ablation).
rwTTR will be assessed as recurrence rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTR for a minimum follow-up of 2 years.
Liver function over time in eeHCC and EMERALD
기간: Liver function will be assessed as the change in liver function markers for a minimum follow-up of 2 years

Liver function markers over time will be examined including the closest measure to the index date in the baseline period of first LRT, from pre-treatment through the follow-up period. The primary summary of interest is the change (or trajectory) in liver function markers (ALBI score and Child-Pugh score) over time.
Liver function will be assessed as the change in liver function markers for a minimum follow-up of 2 years
Provider specialty and treatment patterns in eeHCC
기간: Provider specialty will be assessed descriptively and treatment patterns will be assessed as a percentage of participants for a minimum follow-up of 2 years

Provider specialty characteristics will be described. The percentage of participants receiving LRT as subsequent line of treatment (among participants receiving only LRT as standard of care).
Provider specialty will be assessed descriptively and treatment patterns will be assessed as a percentage of participants for a minimum follow-up of 2 years
Clinical characteristics in EMERALD and eeHCC
기간: Clinical characteristics will be assessed descriptively for a minimum follow-up of 2 years.

The percentage of participants who receive subsequent curative resection or liver transplant will be described.
Clinical characteristics will be assessed descriptively for a minimum follow-up of 2 years.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

ICON plc

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

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)

2023년 12월 20일

기본 완료 (추정된)

2030년 12월 30일

연구 완료 (추정된)

2030년 12월 30일

연구 등록 날짜

최초 제출

2023년 12월 21일

QC 기준을 충족하는 최초 제출

2024년 2월 1일

처음 게시됨 (실제)

2024년 2월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 27일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D419CR00035

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Plan to share only the redacted CSR synopsis

IPD 공유 기간

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 공유 액세스 기준

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD 공유 지원 정보 유형

  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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