건강한 참가자 및 만성 B형 간염 환자의 GSK3965193 단독 연구 및 베피로비르센 병용 연구
2026년 5월 19일 업데이트: GlaxoSmithKline
건강한 참가자 및 함께 생활하는 참가자에서 GSK3965193 단일 요법의 안전성, 내약성, 약동학 및 약력학을 평가하기 위한 4부, 무작위, 이중 맹검(1부, 2A, 3부 및 4부), 다기관, 위약 대조 연구 만성 B형 간염 감염; 및 만성 B형 간염 감염을 앓고 있는 참가자의 베피로비르센과 병용한 GSK3965193
이 1/2a상 다중 파트 연구는 GSK3965193의 단일(파트 1) 및 반복 투여(파트 2)의 안전성, 내약성 및 약동학(PK)을 평가하기 위해 설계된 FTIH(first-time-in-human) 연구입니다. 건강한 참가자.
파트 3에서는 만성 B형 간염 감염(PLWCHB) 환자의 B형 간염 바이러스 표면 항원(HBsAg)을 낮추는 GSK3965193의 능력을 평가합니다.
4부에서는 GSK3965193과 베피로비르센을 사용한 병용 요법의 안전성과 내약성, 그리고 PLWCHB에서 지속적인 바이러스 반응을 일으킬 가능성을 평가합니다.
연구 개요
연구 유형
중재적
등록 (실제)
74
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Daegu, 대한민국, 41944
- GSK Investigational Site
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Pusan, 대한민국, 49241
- GSK Investigational Site
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Seoul, 대한민국, 05505
- GSK Investigational Site
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Cambridge, 영국, CB2 2GG
- GSK Investigational Site
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London, 영국, SW17 0QT
- GSK Investigational Site
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London, 영국, W2 1NY
- GSK Investigational Site
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Milan, 이탈리아, 20122
- GSK Investigational Site
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Monza MB, 이탈리아, 20900
- GSK Investigational Site
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Alberta
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Calgary, Alberta, 캐나다, T2N 4Z6
- GSK Investigational Site
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Ontario
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Ottawa, Ontario, 캐나다, K1H 8L6
- GSK Investigational Site
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Bangkok, 태국, 10330
- GSK Investigational Site
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Grenoble, 프랑스, 38043
- GSK Investigational Site
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Nantes, 프랑스, 44000
- GSK Investigational Site
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Rennes, 프랑스, 35033
- GSK Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 파트 1 및 2: 정보에 입각한 동의서에 서명할 당시 18세에서 55세 사이의 참가자.
- 파트 3 및 4: 정보에 입각한 동의서에 서명할 당시 18세에서 65세 사이의 참여자.
- 체중 >=50 킬로그램(kg) 및 18-32 킬로그램/제곱미터(kg/m^2) 범위 내의 체질량 지수(포함).
- 남성 또는 여성 참가자: a. 파트 1 및 2: 임신 가능성이 없는 여성만. 비. 파트 3 및 4: 임신 또는 모유 수유 중이 아니며 매우 효과적인 피임법을 사용하는 가임 여성 또는 가임 여성.
- 서명된 사전 동의를 제공할 수 있습니다.
- PLWCHB에 대한 추가 포함 기준(3부 및 4부).
- 스크리닝 6개월 이전에 만성 B형 간염 바이러스(HBV) 감염이 기록된 참가자.
- 현재 안정적인 NA 요법(예: 테노포비르 디소프록실, 테노포비르 알라페나미드, 엔테카비르)을 받고 있는 참가자.
- 혈장 또는 혈청 HBsAg 농도 >100 IU/mL.
- 혈장 또는 혈청 HBV 데옥시리보핵산(DNA) 농도
- B형 간염 바이러스 e-항원(HBeAg) 양성 또는 음성.
- 알라닌 아미노전이효소(ALT)
제외 기준:
- 건강한 참가자의 제외 기준:
- A형 간염 바이러스 항체(HAV Ab 면역글로불린 M[IgM]) 양성 또는 HBV, C형 간염 바이러스(HCV) 또는 인체 면역결핍 바이러스(HIV) 양성
- ALT >1배 ULN.
- 빌리루빈 >1.5배 ULN(단리 빌리루빈 >1.5배 ULN은 빌리루빈이 분할되고 직접 빌리루빈인 경우 허용됩니다.
- 수정된 QT 간격(QTc) >450밀리초(msec).
- 코로나바이러스 질병 2019(COVID-19)를 암시하는 징후 및 증상.
- 지난 14일 동안 알려진 COVID-19 양성 접촉이 있는 참가자.
- 파트 2A 참가자의 경우: i. 말초신경병증의 개인력 또는 가족력. ii. 다발신경병증에 대한 토론토 임상 점수 시스템의 점수 >=4.
- 스크리닝 전 6개월 이내에 담배 또는 니코틴 함유 제품(예: (예:) 담배, 니코틴 패치 또는 전자 장치)의 현재 또는 이전 사용 및/또는 5갑년 초과의 흡연 팩 이력이 있는 경우.
- PLWCHB에 대한 제외 기준:
- 만성 HBV 감염을 제외하고 병력에서 임상적으로 유의미한 이상.
- HCV, HIV 또는 D형 간염 바이러스(HDV)와의 동시 감염 또는 과거 병력.
- 간경변의 병력 또는 의심 및/또는 간경변의 증거.
- 간세포 암종으로 진단되거나 의심됩니다.
- 외과적 절제로 완치되는 특정 암(예: 피부암)을 제외하고 지난 5년 이내에 악성 종양의 병력.
- 혈관염의 병력 또는 잠재적인 혈관염의 증상 및 징후의 존재[예: 혈관염 발진, 피부 궤양, 확인된 원인 없이 소변에서 반복되는 혈액이 검출됨] 또는 혈관염 상태와 관련될 수 있는 다른 질병의 병력/존재(예: 전신성 홍반성 루푸스) , 류마티스 관절염, 재발성 다발연골염, 다발성 단일신경염).
- HBV 면역 상태(예: 신증후군, 모든 유형의 사구체신염, 결절성 다발동맥염, 한랭글로불린혈증, 조절되지 않는 고혈압)와 관련이 있을 수 있는 간외 질환의 병력.
- 알코올 또는 약물 남용/의존 병력: a. 참가자 준수를 잠재적으로 방해할 수 있다고 조사관이 판단한 현재 알코올 사용. 비. 참가자 순응을 잠재적으로 방해하는 것으로 조사관이 판단한 현재 약물 남용/의존 이력 또는 현재.
- 식도 정맥류 출혈의 병력 또는 기타 증거.
- 무작위화 1년 이내에 대사성 간 질환의 문서화된 병력 또는 기타 증거.
- 말초신경병증의 개인력 또는 가족력.
- 다발신경병증에 대한 토론토 임상 점수 시스템의 점수 >4.
- 연구 약물의 첫 번째 투여 전 8주 이내에 임의의 전신 항신생물(방사선 포함) 또는 면역 조절 치료(전신 경구 코르티코스테로이드, 인터페론 또는 페길화된 인터페론 포함)를 받았거나 현재 받고 있는 이력 또는 그러한 치료가 연구 중 언제든지 필요할 것입니다.
- 비정상적이고 임상적으로 중요한 12-리드 ECG 소견.
- 단기 요법 이외의 면역억제제(예: 프레드니손)를 현재 복용 중이거나 스크리닝 후 3개월 이내에 복용(
- 항응고 요법이 필요한 참가자.
- 첫 번째 투여일 전 12개월 이내에 임의의 올리고뉴클레오티드 또는 작은 간섭 RNA(siRNA)로 사전 치료.
- COVID-19 감염에 대한 양성 테스트.
- 지난 14일 동안 알려진 COVID-19 양성 접촉이 있는 참가자.
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: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Part 1: Cohort 1 - Placebo/GSK3965193 Dose 2/Dose 3/Dose 4
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 2.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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실험적: Part 1: Cohort 1 - GSK3965193 Dose 1/Placebo/Dose 3/Dose 4
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 1.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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실험적: Part 1: Cohort 1 - GSK3965193 Dose 1/Dose 2/Placebo/Dose 4
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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실험적: Part 1: Cohort 1 - GSK3965193 Dose 1/Dose 2/Dose 3/Placebo
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 3 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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실험적: Part 1: Cohort 2 - Placebo/GSK3965193 Dose 6/Dose 7/Dose 8
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 6.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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실험적: Part 1: Cohort 2 - GSK3965193 Dose 5/Placebo/Dose 7/Dose 8
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 5.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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실험적: Part 1: Cohort 2 - GSK3965193 Dose 5/Dose 6/Placebo/Dose 8
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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실험적: Part 1: Cohort 2 - GSK3965193 Dose 5/Dose 6/Dose 7/Placebo
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 7 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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위약 비교기: Part 2A: Placebo
Healthy participants received repeat doses of placebo oral solution twice daily (BID) for 14 days.
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Placebo to match GSK3965193 was administered
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실험적: Part 2A: Cohort 5 - GSK3965193 Dose 9 BID
Healthy participants received repeat doses of GSK3965193 Dose 9 oral solution BID for 14 days.
Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
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GSK3965193 was administered
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실험적: Part 2A: Cohort 3 - GSK3965193 Dose 5 BID
Healthy participants received repeat doses of GSK3965193 Dose 5 oral solution BID for 14 days.
Dose 5 of GSK3965193 was higher than Dose 9 but lower than Dose 10.
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GSK3965193 was administered
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실험적: Part 2A: Cohort 4 - GSK3965193 Dose 6 BID
Healthy participants received repeat doses of GSK3965193 Dose 6 oral solution BID for 14 days.
Dose 6 of GSK3965193 was higher than Dose 10 but lower than Dose 7.
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GSK3965193 was administered
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실험적: Part 2B: Cohort 6 - GSK3965193 Dose 10 Fasted/Fed
Healthy participants received GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
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GSK3965193 was administered
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실험적: Part 2B: Cohort 6 - GSK3965193 Dose 10 Fed/Fasted
Healthy participants received GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
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GSK3965193 was administered
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위약 비교기: Part 3: Cohort 7 - Placebo
Participants living with chronic hepatitis B infection (PLWCHB) on stable nucleos(t)ide analog (NA) therapy received repeat doses of placebo oral tablets for 28 days.
Participants who completed placebo monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen subcutaneous (SC) injection from Day 43.
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Placebo to match GSK3965193 was administered
Bepirovirsen was administered
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실험적: Part 3: Cohort 7 - GSK3965193 Dose 9
PLWCHB on stable NA therapy received repeat doses of GSK3965193 Dose 9 oral tablets for 28 days.
Participants who completed GSK3965193 monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen SC injection from Day 43.
Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
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GSK3965193 was administered
Bepirovirsen was administered
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실험적: Part 4: Cohort 8 - Placebo + Bepirovirsen
PLWCHB on stable NA therapy were planned to receive placebo oral tablets plus bepirovirsen SC injection for 28 days.
All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
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Placebo to match GSK3965193 was administered
Bepirovirsen was administered
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실험적: Part 4: Cohort 8 - GSK3965193 + Bepirovirsen
PLWCHB on stable NA therapy were planned to receive GSK3965193 oral tablets plus bepirovirsen SC injection for 28 days.
All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
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GSK3965193 was administered
Bepirovirsen was administered
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Treatment Emergent Adverse Events (STEAEs), and Treatment Withdrawals Due to TEAEs
기간: From the start of study intervention (Day 1) up to 12 weeks
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset date was on or after study intervention start date (i.e., Day 1) till Day 5 after study intervention administration.
Any AE which started post Day 5 of study intervention administration was not considered as TEAE.
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From the start of study intervention (Day 1) up to 12 weeks
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Part 2A: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
기간: From the start of study intervention (Day 1) up to 6 weeks
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset date was on or after study intervention start date.
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From the start of study intervention (Day 1) up to 6 weeks
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Part 2B: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
기간: From the start of study intervention (Day 1) up to 9 weeks
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset date was on or after study intervention start date (i.e., Day 1) till Day 5 after study intervention administration.
Any AE which started post Day 5 of study intervention administration was not considered as TEAE.
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From the start of study intervention (Day 1) up to 9 weeks
|
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Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
기간: From the start of study intervention (Day 1) up to 6 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset or worsen date was on or after study intervention start date.
Data for the placebo or GSK3965193 monotherapy phase were presented.
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From the start of study intervention (Day 1) up to 6 weeks
|
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Part 4: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
기간: From the start of study intervention (Day 1) up to 48 weeks
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE would be considered treatment emergent if the AE onset or worsen date was on or after study intervention start date.
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From the start of study intervention (Day 1) up to 48 weeks
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Part 1: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
기간: At Day 2
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Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, RBC indices (mean corpuscular volume [MCV] and mean corpuscular hemoglobin [MCH]), white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Clinical significance of laboratory parameters was determined by the investigator.
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At Day 2
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Part 2A: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
기간: Up to 21 days
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Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Urine samples were analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters was determined by the investigator.
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Up to 21 days
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Part 2B: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
기간: Up to 9 weeks
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Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Urine samples were analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters was determined by the investigator.
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Up to 9 weeks
|
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Part 3: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
기간: Up to 35 days
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Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Clinical significance of laboratory parameters was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
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Up to 35 days
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Part 3: Number of Participants With Clinically Significant Urinalysis Parameters
기간: Up to 28 days
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Urine samples were analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
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Up to 28 days
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Part 4: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
기간: Up to 48 weeks
|
Blood samples were planned to be collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Urine samples were planned to be analyzed using automated urinalysis or urine dipstick.
Microscopic examination was planned to be performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters would be determined by the investigator.
|
Up to 48 weeks
|
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Part 1: Number of Participants With Clinically Significant Vital Sign Findings
기간: Up to 12 weeks
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Vital signs included systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
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Up to 12 weeks
|
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Part 2A: Number of Participants With Clinically Significant Vital Sign Findings
기간: Up to 21 days
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Vital signs included SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
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Up to 21 days
|
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Part 2B: Number of Participants With Clinically Significant Vital Sign Findings
기간: Up to 9 weeks
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Vital signs included SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
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Up to 9 weeks
|
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Part 3: Number of Participants With Clinically Significant Vital Sign Findings
기간: Up to 35 days
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Vital signs included temperature, SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
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Up to 35 days
|
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Part 4: Number of Participants With Clinically Significant Vital Signs Findings
기간: Up to 48 weeks
|
Vital signs were planned to include temperature, SBP and DBP, pulse and respiratory rate and were planned to be measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings would be determined by the investigator.
|
Up to 48 weeks
|
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Part 1: Number of Participants With Clinically Significant Electrocardiogram [ECG] Findings
기간: Up to 12 weeks
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A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters collected were PR, QRS, QT, and corrected QT (QTc) intervals.
Clinical significance of ECG parameters was determined by the investigator.
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Up to 12 weeks
|
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Part 2A: Number of Participants With Clinically Significant ECG Findings
기간: Up to 21 days
|
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters collected were PR, QRS, QT, and QTc intervals.
Clinical significance of ECG parameters was determined by the investigator.
|
Up to 21 days
|
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Part 3: Number of Participants With Clinically Significant ECG Findings
기간: Up to 35 days
|
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters collected were PR, QRS, QT, and QTc intervals.
Clinical significance of ECG parameters was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
|
Up to 35 days
|
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Part 4: Number of Participants With Clinically Significant ECG Findings
기간: Up to 25 weeks
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A 12-lead ECG was planned to be recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters planned to be collected were PR, QRS, QT, and QTc intervals.
Clinical significance of ECG findings would be determined by the investigator.
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Up to 25 weeks
|
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Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 7
기간: Baseline and Day 7
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Sensory nerve conduction testing was performed to detect neuropathy in participants.
Nerve conduction velocity (NCV) and nerve conduction amplitude were determined.
Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing.
Mean (arithmetic mean) of two measurements were considered as Baseline.
Number of participants with 25 percent (%) decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 7 was reported.
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Baseline and Day 7
|
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Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 14
기간: Baseline and Day 14
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing.
Mean (arithmetic mean) of two measurements were considered as Baseline.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 14 was reported.
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Baseline and Day 14
|
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Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 42
기간: Baseline and Day 42
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing.
Mean (arithmetic mean) of two measurements were considered as Baseline.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 42 was reported.
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Baseline and Day 42
|
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Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 15
기간: Baseline and Day 15
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
The best measurement out of Screening and Day -1 was considered as Baseline, best being the higher measurement.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 15 for the placebo or GSK3965193 monotherapy phase was reported.
|
Baseline and Day 15
|
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Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 29
기간: Baseline and Day 29
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
The best measurement out of Screening and Day -1 was considered as Baseline, best being the higher measurement.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 29 for the placebo or GSK3965193 monotherapy phase was reported.
|
Baseline and Day 29
|
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Part 4: Number of Participants With Changes in Sensory Nerve Conduction
기간: Baseline up to 29 days
|
Sensory nerve conduction testing was planned to be performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were planned to be determined.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from baseline was planned to be reported.
|
Baseline up to 29 days
|
|
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3965193 Following Single Dose Administration
기간: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours (h) post-dose
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours (h) post-dose
|
|
Part 2A: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 15 minutes (min), 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, and 12 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
As the dosing interval Tau was 12 hours, AUC(0-tau) is the same as AUC from time zero to 12 hours after dosing (AUC[0-12]).
|
Pre-dose and 15 minutes (min), 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, and 12 h post-first dose on Day 14
|
|
Part 1: Maximum Observed Concentration (Cmax) of GSK3965193 Following Single Dose Administration
기간: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
|
Part 2A: Cmax of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
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Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
|
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3965193 Following Single Dose Administration
기간: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
|
Part 2A: Tmax of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
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Part 1: Apparent Terminal Half-life (T1/2) of GSK3965193 Following Single Dose Administration
기간: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
|
Part 2A: T1/2 of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
|
Part 3: Maximum Reduction of Serum HBsAg Levels From Baseline
기간: From Baseline (Pre-dose on Day 1) up to 6 weeks
|
Blood samples were collected from participants to assess HBsAg levels for the placebo or GSK3965193 monotherapy phase.
Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Posterior mean and associated 95 percent (%) credible interval were derived for maximum reduction of serum HBsAg levels from Baseline using Bayesian mixed model repeated measures.
The data presented are mean referring to posterior mean, with 95% confidence interval referring to 95% credible interval.
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From Baseline (Pre-dose on Day 1) up to 6 weeks
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Part 4: Number of Participants Achieving Complete Response
기간: Up to 48 weeks
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Blood samples were planned to be collected to assess HBsAg and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels.
Complete response is defined HBsAg and HBV DNA below lower limit of quantification (LLOQ) for 6 consecutive months after the planned end of treatment.
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Up to 48 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part 2B: AUC(0-inf) of GSK3965193 Following Single Dose Administration
기간: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
|
Part 2B: Cmax of GSK3965193 Following Single Dose Administration
기간: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
|
Part 3: AUC(0-tau) of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: Cmax of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: Tmax of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: T1/2 of GSK3965193 Following Repeat Dose Administration
기간: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: Number of Participants With Greater Than or Equal to [≥] 0.5 Times Log International Units Per Milliliters [IU/mL] Reduction From Baseline in Serum HBsAg Levels
기간: From Baseline (Day 1) up to 42 days
|
Blood samples were collected from participants at indicated time points to assess HBsAg levels.
|
From Baseline (Day 1) up to 42 days
|
|
Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs Among Participants Opting for Optional Bepirovirsen Treatment
기간: From the start of study intervention up to 54 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
|
From the start of study intervention up to 54 weeks
|
|
Part 3: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters Among Participants Opting for Optional Bepirovirsen Treatment
기간: From Week 7 up to 54 weeks
|
Blood samples were planned to be collected to analyze clinical chemistry and hematology parameters: hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, ALT, albumin, alkaline phosphatase, AST, bilirubin, calcium corrected for albumin, creatinine, glucose, potassium, and sodium.
Urine samples were planned to be analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Number of participants with clinically significant clinical chemistry, hematology, and urinalysis parameters were reported.
Clinical significance was determined by the investigator.
|
From Week 7 up to 54 weeks
|
|
Part 3: Number of Participants With Clinically Significant Vital Signs Among Participants Opting for Optional Bepirovirsen Treatment
기간: From Week 7 up to 54 weeks
|
Vital signs were planned to include temperature and were planned to be measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of vital signs was determined by the investigator.
|
From Week 7 up to 54 weeks
|
|
Part 4: Number of Participants With HBsAg Loss
기간: Up to 48 weeks
|
Blood samples were collected from participants at indicated time points to assess HBsAg levels.
HBsAg loss is defined by two consecutive measurements of HBsAg below the LLOQ any time during the study (on-treatment and post-treatment).
|
Up to 48 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: GSK Clinical Trials, GlaxoSmithKline
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)
2022년 4월 14일
기본 완료 (실제)
2025년 5월 19일
연구 완료 (실제)
2026년 4월 8일
연구 등록 날짜
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 214760
- 2021-005117-13 (EudraCT 번호)
- 2023-509684-24 (기타 식별자: EU CTR)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
이 연구에 대한 IPD는 임상 연구 데이터 요청 사이트를 통해 제공됩니다.
IPD 공유 기간
IPD는 연구의 1차 종점, 주요 2차 종점 및 안전성 데이터의 결과를 발표한 후 6개월 이내에 제공될 예정입니다.
IPD 공유 액세스 기준
액세스는 연구 제안서가 제출되고 독립 검토 패널의 승인을 받은 후 데이터 공유 계약이 체결된 후에 제공됩니다.
액세스는 초기 12개월 동안 제공되지만 정당한 경우 최대 12개월까지 연장할 수 있습니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
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. .