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

만성 B형 간염(CHB) 환자를 대상으로 다플루시란/톰리기시란(DAP/TOM) 및 베피로비르센을 이용한 순차적 치료에 대한 연구 (B-UNITED)

2026년 11월 4일 업데이트: GlaxoSmithKline

배경 핵(t)유사체 유사체에 만성 B형 간염 바이러스가 있는 참가자를 대상으로 다플루시란/톰리기시란에 이어 베피로비르센을 투여하는 순차 치료의 안전성과 유효성을 조사하기 위한 제2b상 다기관, 무작위 배정, 부분 위약 대조, 이중 맹검 연구 치료 (B-유나이티드)

The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to assess the contribution of DAP/TOM to the sequential regimen. The study will also include an optional long-term follow-up (LTFU) extension stage for eligible participants.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

283

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 그리스
      • Athens, 그리스, 10676
        • GSK Investigational Site
      • Athens, 그리스, 11527
        • GSK Investigational Site
  • 남아프리카
      • Ekurhuleni, 남아프리카, 1459
        • GSK Investigational Site
      • Johannesburg, 남아프리카, 2193
        • GSK Investigational Site
  • 뉴질랜드
      • Auckland, 뉴질랜드, 2025
        • GSK Investigational Site
      • Auckland, 뉴질랜드, 1023
        • GSK Investigational Site
  • 대만
      • Kaohsiung City, 대만, 807
        • GSK Investigational Site
      • Kaohsiung City, 대만, 824
        • GSK Investigational Site
      • Taichung, 대만, 404
        • GSK Investigational Site
      • Tau-Yuan, 대만, 333
        • GSK Investigational Site
  • 대한민국
      • Ansan, 대한민국, 15355
        • GSK Investigational Site
      • Busan, 대한민국, 47392
        • GSK Investigational Site
      • Pusan, 대한민국, 49241
        • GSK Investigational Site
      • Seoul, 대한민국, 138-736
        • GSK Investigational Site
      • Seoul, 대한민국, 07061
        • GSK Investigational Site
  • 독일
      • Berlin, 독일, 10787
        • GSK Investigational Site
      • Berlin, 독일, 10439
        • GSK Investigational Site
      • Münster, 독일, 48149
        • GSK Investigational Site
    • Lower Saxony
      • Hanover, Lower Saxony, 독일, 30625
        • GSK Investigational Site
  • 미국
    • California
      • San Francisco, California, 미국, 94115
        • GSK Investigational Site
      • San Jose, California, 미국, 95116
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55415
        • GSK Investigational Site
    • New York
      • New York, New York, 미국, 10029
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • GSK Investigational Site
  • 벨기에
      • Brussels, 벨기에, 1000
        • GSK Investigational Site
      • Edegem, 벨기에, 2650
        • GSK Investigational Site
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, 벨기에, 9000
        • GSK Investigational Site
  • 브라질
      • Aracaju, 브라질, 49060-010
        • GSK Investigational Site
      • Curitiba, 브라질, 80810-050
        • GSK Investigational Site
      • Manaus, 브라질, 69040-000
        • GSK Investigational Site
      • São Paulo, 브라질, 05403-000
        • GSK Investigational Site
  • 스페인
      • Barcelona, 스페인, 08036
        • GSK Investigational Site
      • Barcelona, 스페인, 08035
        • GSK Investigational Site
      • León, 스페인, 24080
        • GSK Investigational Site
      • Madrid, 스페인, 28041
        • GSK Investigational Site
      • Salamanca, 스페인, 37007
        • GSK Investigational Site
      • Santander, 스페인, 39008
        • GSK Investigational Site
      • Valencia, 스페인, 46026
        • GSK Investigational Site
  • 싱가포르
      • Singapore, 싱가포르, 119074
        • GSK Investigational Site
      • Singapore, 싱가포르, 169608
        • GSK Investigational Site
  • 영국
      • London, 영국, SE5 9RS
        • GSK Investigational Site
      • London, 영국, SW17 0QT
        • GSK Investigational Site
      • London, 영국, E1 8PR
        • GSK Investigational Site
      • Middlesbrough, 영국, TS4 3BW
        • GSK Investigational Site
  • 이탈리아
      • Bergamo, 이탈리아, 24127
        • GSK Investigational Site
      • Florence, 이탈리아, 50134
        • GSK Investigational Site
      • Milan, 이탈리아
        • GSK Investigational Site
      • Naples, 이탈리아, 80131
        • GSK Investigational Site
      • Padova, 이탈리아, 35131
        • GSK Investigational Site
      • Pisa, 이탈리아, 56124
        • GSK Investigational Site
      • Roma, 이탈리아, 00161
        • GSK Investigational Site
  • 일본
      • Chiba, 일본, 270-1694
        • GSK Investigational Site
      • Hokkaido, 일본, 006-8555
        • GSK Investigational Site
      • Hokkaido, 일본, 053-8506
        • GSK Investigational Site
      • Hyōgo, 일본, 660-8550
        • GSK Investigational Site
      • Kagawa, 일본, 761-0793
        • GSK Investigational Site
      • Kagawa, 일본, 760-8557
        • GSK Investigational Site
      • Kumamoto, 일본, 860-8556
        • GSK Investigational Site
      • Kumamoto, 일본, 862-8655
        • GSK Investigational Site
      • Osaka, 일본, 540-0006
        • GSK Investigational Site
      • Osaka, 일본, 565-0871
        • GSK Investigational Site
      • Tokyo, 일본, 180-8610
        • GSK Investigational Site
      • Yamanashi, 일본, 409-3898
        • GSK Investigational Site
  • 중국
      • Beijing, 중국, 100050
        • GSK Investigational Site
      • Chengdu, 중국, 610072
        • GSK Investigational Site
      • Guangzhou, 중국, 510630
        • GSK Investigational Site
      • Shanghai, 중국, 200040
        • GSK Investigational Site
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4Z6
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, 캐나다, K1H8L6
        • GSK Investigational Site
      • Toronto, Ontario, 캐나다, M5G 2C4
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, 캐나다, H4A 3J1
        • GSK Investigational Site
  • 프랑스
      • Clichy, 프랑스, 92118
        • GSK Investigational Site
      • Créteil, 프랑스, 94010
        • GSK Investigational Site
      • Limoges, 프랑스, 87042
        • GSK Investigational Site
      • Lyon, 프랑스, 69004
        • GSK Investigational Site
      • Marseille, 프랑스, 13008
        • GSK Investigational Site
  • 호주
    • New South Wales
      • Westmead, New South Wales, 호주, 2145
        • GSK Investigational Site
    • Victoria
      • Fitzroy, Victoria, 호주, 3065
        • GSK Investigational Site
  • 홍콩
      • Pokfulam, 홍콩
        • GSK Investigational Site
      • Shatin, 홍콩
        • GSK Investigational Site

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age: At least 18 years of age at the time of signing the informed consent
  • Documented chronic HBV infection greater than or equal to (>=) 6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no planned changes to their stable regimen over the duration of the study.
  • Plasma or serum HBsAg concentration greater than (>) 100 international units per milliliter (IU/mL)
  • Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA less than (<) 90 IU/mL
  • Alanine aminotransferase less than or equal to (<=) 2* upper limit of normal (ULN)
  • Participants who are willing and able to cease their NA treatment in accordance with the protocol.
  • Male and Female

Exclusion Criteria:

  • Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings.
  • Coinfection with Hepatitis C (cured <12 months at the time of screening), Human immunodeficiency virus or hepatitis D virus
  • History of or suspected liver cirrhosis and/or evidence of cirrhosis.
  • Diagnosed or suspected hepatocellular carcinoma.
  • History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (example, skin cancer). Participants under evaluation for possible malignancy are not eligible.
  • History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (example, systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
  • History of extrahepatic disorders possibly related to HBV immune conditions (example, nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
  • History of alcohol or drug abuse/dependence:
  • Currently taking, or took within 3 months of screening, any immunosuppressing drugs (example, prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use.
  • Participants, to whom immunosuppressive treatment (including therapeutic doses of steroids) is contraindicated, should not be considered for enrollment in the study.
  • Currently taking, or has taken within 6 months of Screening, any interferon-containing therapy.
  • Participants requiring anti-coagulation therapies (example, warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of Investigational medicinal product (IMP) treatment, by the discretion of the investigator. Occasional use is permitted.
  • Prior hepatitis B treatment with bepirovirsen, DAP/TOM, or another oligonucleotide or small interfering RNA (siRNA).
  • Prior non-hepatitis B treatment with an oligonucleotide or siRNA within 12 months prior to the first dosing day.
  • Fridericia's QT correction formula (QTcF) >=450 millisecond (msec) (if single electrocardiogram [ECG] at screening shows QTcF >=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).
  • History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
  • Participants who do not wish to discontinue taking NA therapy for their chronic HBV infection.

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: 순차적 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment Arm 1A: DAP/TOM + Bepirovirsen

Participants with high Hepatitis B surface antigen (HBsAg) level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM Treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
의약품: Daplusiran/Tomligisiran Dose Level 1

Daplusiran/Tomligisiran dose level 1 will be administered

의약품: Bepirovirsen

Bepirovirsen will be administered
실험적: Treatment Arm 1B: DAP/TOM + Bepirovirsen

Participants with high HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
의약품: Bepirovirsen

Bepirovirsen will be administered

의약품: Daplusiran/Tomligisiran Dose Level 2

Daplusiran/Tomligisiran dose level 2 will be administered
실험적: Treatment Arm 2A: DAP/TOM + Bepirovirsen

Participants with low HBsAg level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
의약품: Daplusiran/Tomligisiran Dose Level 1

Daplusiran/Tomligisiran dose level 1 will be administered

의약품: Bepirovirsen

Bepirovirsen will be administered
실험적: Treatment Arm 2B: DAP/TOM + Bepirovirsen

Participants with low HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
의약품: Bepirovirsen

Bepirovirsen will be administered

의약품: Daplusiran/Tomligisiran Dose Level 2

Daplusiran/Tomligisiran dose level 2 will be administered
실험적: Treatment Arm 2C: Placebo + Bepirovirsen

Participants with low HBsAg level will receive Placebo in Treatment Stage 1. After Placebo treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
의약품: Placebo

Placebo will be administered

의약품: Bepirovirsen

Bepirovirsen will be administered

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of participants achieving functional cure
기간: Up to 100 Weeks

The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV deoxyribonucleic acid (DNA) <lower limit of quantification (LLOQ) and HBsAg not detected with or without HBsAb after a finite duration of therapy and off all HBV treatment. The number of participants achieving functional cure after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) will be reported.
Up to 100 Weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants achieving functional cure with high Baseline HBsAg level
기간: Up to 100 Weeks

The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV DNA <LLOQ and HBsAg not detected with or without HBsAb after a finite duration of therapy and off all HBV treatment. The number of participants achieving functional cure with high Baseline HBsAg level after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) will be reported.
Up to 100 Weeks
Number of participants achieving functional cure with low Baseline HBsAg level
기간: Up to 100 Weeks

The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV DNA <LLOQ and HBsAg not detected with or without HBsAb after a finite duration of therapy and off all HBV treatment. The number of participants achieving functional cure with low Baseline HBsAg level after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) will be reported.
Up to 100 Weeks
Number of participants achieving functional cure with low Baseline HBsAg level compared against placebo + bepirovirsen arm
기간: Up to 100 Weeks

The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV DNA <LLOQ and HBsAg not detected with or without HBsAb after a finite duration of therapy and off all HBV treatment. The number of participants achieving functional cure with low Baseline HBsAg level after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) compared against placebo + bepirovirsen arm will be reported.
Up to 100 Weeks
Number of participants with undetected HBsAg and HBV DNA <LLOQ
기간: Up to 48 Weeks

The number of participants with undetected HBsAg and HBV DNA <LLOQ at the end of bepirovirsen treatment will be reported.
Up to 48 Weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

수사관

  • 연구 책임자: GSK Clinical Trials, GlaxoSmithKline

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)

2024년 11월 11일

기본 완료 (추정된)

2027년 5월 31일

연구 완료 (추정된)

2030년 5월 17일

연구 등록 날짜

최초 제출

2024년 8월 1일

QC 기준을 충족하는 최초 제출

2024년 8월 1일

처음 게시됨 (실제)

2024년 8월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 218309
  • 2024-514507-33-00 (씨티스)
  • 2024-514507-33-00 (레지스트리 식별자: CTIS (EU))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD 공유 기간

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD 공유 액세스 기준

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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. .

구독하다