- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03752658
TAF Real World Study for Universal Effectiveness (TRUE)
A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
연구 개요
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Qin Ning, MD., Ph.D.
- 전화번호: +86 278366 2391
- 이메일: qning@vip.sina.com
연구 연락처 백업
- 이름: Di Wu, MD., Ph.D.
- 전화번호: +86 278366 2391
- 이메일: woody_1984@163.com
연구 장소
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Hangzhou, 중국
- 모병
- Shulan(Hangzhou) hospitai
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연락하다:
- Zhe Yu
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수석 연구원:
- Zhe Yu
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Nanchang, 중국
- 모병
- First Affiliated Hospital of Nanchang University
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연락하다:
- Xiaoping Wu, Doctor
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Shanghai, 중국
- 모병
- Shanghai public health clinic
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연락하다:
- Liang Chen
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수석 연구원:
- Liang Chen
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Wuhan, 중국
- 아직 모집하지 않음
- General Hospital of The Yangtze River Shipping
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연락하다:
- Lvye Xu
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수석 연구원:
- Lvye Xu
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Wuhan, 중국
- 모병
- The Seventh Hospital of Wuhan
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연락하다:
- Youqin Yan
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수석 연구원:
- Youqin Yan
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Xiangya, 중국
- 모병
- Xiangya Hospital of Central South University
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수석 연구원:
- Yan Huang
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Hubei
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Wuhan, Hubei, 중국, 430030
- 아직 모집하지 않음
- Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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연락하다:
- Qin Ning, Prof.
- 전화번호: 862883662391
- 이메일: qning@vip.sina.com
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수석 연구원:
- Qin Ning, Doctor
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수석 연구원:
- Di Wu, Doctor
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Males and non-pregnant, non-lactating female patients with HBsAg positive > 6 months above 18 years of age; Documented evidence of chronic HBV infection previously; HBV mono-infected HBeAg positive or negative; NA treatment-naive and treatment-experienced; TAF naive; Agree to participate in the study and sign the patient informed consent.
Subjects coinfected with HCV, hepatitis D virus (HDV), human immunodeficiency virus (HIV) or who have received TAF or who haveChild-Pugh C decompensated liver disease or HCC will be excluded.
설명
Inclusion Criteria:
- Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures
- Adult males and nonpregnant, nonlactating females
- Documented evidence of chronic HBV infection previously
- TAF naive
Exclusion Criteria:
- Patents who were TAF experienced
- Women who are breastfeeding
- Pregnant females
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
- Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis)
- Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy
- Abnormal hematological and biochemical parameters, including:
- Albumin < 2.8 mg/ dL
- International normalized ratio (INR) > 2.3 X ULN (unless stable on anticoagulant regimen)
- Total bilirubin > 3 X ULN
- Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
- Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
- Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- Use of investigational agents within 3 months of screening, unless allowed by the sponsor
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Tenofovir alafenamide (TAF)
Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents.
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The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
proportion of participants with HBV DNA < 20 IU/mL
기간: 36 months
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proportion of participants with HBV DNA < 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months
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36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The proportion of patients with HBV DNA < 20 IU/mL
기간: 12 months
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The proportion of patients with HBV DNA < 20 IU/mL at 12 months
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12 months
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The proportion of patients with HBV DNA <300 copies/mL
기간: 12 months
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The proportion of patients with HBV DNA <300 copies/mL at 12 months
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12 months
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The proportion of patients with HBV DNA < 20 IU/mL
기간: 24 months
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The proportion of patients with HBV DNA < 20 IU/mL at 24 months
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24 months
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The proportion of patients with HBV DNA <300 copies/mL IU/mL
기간: 24 months
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The proportion of patients with HBV DNA <300 copies/mL at 24 months
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24 months
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The proportion of patients with HBV DNA <300 copies/mL IU/mL
기간: 36 months
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The proportion of patients with HBV DNA <300 copies/mL at 36 months
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36 months
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Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss
기간: 36 months
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Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months
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36 months
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Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)
기간: 36 months
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Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months
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36 months
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Proportion of participants with Normal Alanine Aminotransferase (ALT)
기간: 36 months
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Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months
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36 months
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Change from baseline in fibrosis as assessed by Fibroscan®
기간: 36 months
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Change from baseline in fibrosis as assessed by Fibroscan® at 36 months
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36 months
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Percent Change from baseline in Bone Mineral Density (BMD)
기간: 36 months
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Percent Change from baseline in Bone Mineral Density (BMD) at 36 months
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36 months
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Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
기간: 36 months
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Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months
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36 months
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the rate of mother-to-child transmission of HBV
기간: at postpartum 6 months
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For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate
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at postpartum 6 months
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 연구 의자: Qin Ning, MD., Ph.D., Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IN-US-320-4669
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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