- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00305019
Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus
A Double- Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD and 50 Mg QD Doses in Patients Infected With Hepatitis B Virus
연구 개요
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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Guro-ku, Seoul
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Guro-dong, Guro-ku, Seoul, 대한민국, 152-703
- Korea University Guro Hospital
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Jongno-Gu, Seoul
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Yeongeon-dong, Jongno-Gu, Seoul, 대한민국, 110-744
- Seoul National University
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Kangdong-Gu, Seoul
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Gil-dong, Kangdong-Gu, Seoul, 대한민국, 134-701
- Kangdong Sacred Heart Hospital
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Kangnam-Gu, Seoul
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Dogok-dong, Kangnam-Gu, Seoul, 대한민국, 146-92
- Yongdong Severance Hospital
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Ilwon-dong, Kangnam-Gu, Seoul, 대한민국, 135-710
- Samsung Medical Center
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Songpa-Gu, Seoul
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Pungnab2-dong, Songpa-Gu, Seoul, 대한민국, 388-1
- Asan Medical Center
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Yangchon-Gu, Seoul
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Mok-dong, Yangchon-Gu, Seoul, 대한민국, 911-1
- Ewha Womans University Hospital
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Yougdungpo-Gu, Seoul
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Youido, Yougdungpo-Gu, Seoul, 대한민국, 150-713
- St. Mary's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient who is between 18 and 60 years of age, inclusive
- Patient who is HBV DNA positive with DNA levels at screening more than 3 x 10^6 copies/mL.
Patient who is documented to be hepatitis B surface antigen (HBsAg) positive for > 6 months. Patient is HBeAg positive and anti-HBe negative.
Evidence of HBsAg (+) for the previous 6 months may include the following:
- documentation of HBsAg (+) for the previous 6 months
- documentation of HBsAg (+) for the previous 3 months and IgM anti-HBc negative at screening
- IgM anti-HBc negative and IgG anti-HBc positive at screening
- Patient who has ALT levels which are in the range of more than 2 to less than 10 times the upper limit of normal (x ULN) and bilirubin levels < 1.5 x ULN.
- Female patient with a negative serum (HCG) pregnancy test taken within 14 days of starting therapy.
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Patients who continue to meet the following criteria after completion of the Week 36 visit will have additional follow-up visits at Week 40, 44, 48:
- have received no additional therapy since completion of 12 weeks of treatment of L-FMAU and
- continue with period 1 log10 decrease in HBV DNA from baseline.
Exclusion Criteria:
- Patient who is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
- Patients with previous treatment with interferon that have ended less than 6 months prior to the screening visit.
- Patient who has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient who is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV.
- Patient with clinical evidence of cirrhosis or hepatocellular carcinoma
- Patient who is pregnant or breast-feeding.
- Patient who is unwilling to use an "effective" method of contraception during the study and for up to 30 days after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., intrauterine device [IUD], barrier methods with spermicide or abstinence)
- Patient who has a clinically relevant history of abuse of alcohol or drugs.
- Patient who has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
- Patient who has creatinine clearance less than 60 mL/min as estimated by the following formula:
(140-age in years) (body weight [kg])/ (72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
Patients found to have tyrosine, methionine, aspartate, aspartate (YMDD) HBV DNA polymerase mutation after the enrollment will be excluded from the efficacy evaluation but included in the safety evaluation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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효능: 기준선에서 HBV DNA의 변화(log10)
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2차 결과 측정
결과 측정 |
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안전
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활력 징후
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부작용
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실험실 테스트
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Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
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Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
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Proportion of patients with hepatitis Be antigen (HBeAg) loss
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Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
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Biochemical improvement (e.g., ALT normalization)
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Electrocardiogram (ECG)
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- L-FMAU-201
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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