- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01369199
Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (HBRN)
연구 개요
상세 설명
To determine the efficacy of treatment with 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon in the treatment of chronic hepatitis B in hepatitis B "e" antigen (HBeAg) positive adults who are in the immune tolerant phase.
To evaluate safety and sustained responses after treatment with entecavir and peginterferon alfa-2a in the treatment of chronic hepatitis B in HBeAg positive adults who are in the immune tolerant phase.
A single arm treatment study of 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon alfa-2a in adults with HBeAg-positive chronic hepatitis B with normal or near normal alanine aminotransferase (ALT) levels and high serum levels of hepatitis B virus (HBV) DNA ("immune tolerant" HBeAg-positive chronic hepatitis B). All participants followed for 48 weeks after treatment discontinuation (week 96 for those who completed treatment).
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095
- University of California Los Angeles
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Los Angeles, California, 미국, 90048
- Cedars Sinai Medical Center
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San Francisco, California, 미국, 94143
- University of California San Francisco
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San Francisco, California, 미국, 94115
- California Pacific Medical Center
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- Queen's Medical Center
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Maryland
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Bethesda, Maryland, 미국, 20892
- NIH Clinical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan Health System
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Minnesota
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Minneapolis, Minnesota, 미국, 55446
- University of Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University
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Saint Louis, Missouri, 미국, 63104
- Saint Louis University
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern
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Dallas, Texas, 미국, 75246
- Baylor University Medical Center
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Virginia
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Richmond, Virginia, 미국, 23498
- Virginia Commonwealth University
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Washington
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Seattle, Washington, 미국, 98101
- Virginia Mason Medical Center
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Seattle, Washington, 미국, 98105
- University of Washington Medical Center
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Ontario
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Toronto, Ontario, 캐나다, M5T 2S8
- University of Toronto
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit.
- >18 years of age at the baseline visit (day 0). Patients >50 years of age at baseline will need to have a liver biopsy as standard of care with hepatic activity index (HAI) ≤3 & Ishak fibrosis score ≤1 within 96 weeks prior to baseline visit.
- Documented chronic HBV infection as evidenced by detection of HBsAg in serum for ≥24 weeks prior to baseline visit OR at least one positive HBsAg & negative anti-hepatitis B core (HBc) immunoglobulin (IgM) within 24 weeks prior to baseline visit OR at least one positive HBsAg & two positive HBV DNA over a period of ≥24 weeks prior to baseline visit.
- Presence of HBeAg in serum at last screening visit within 6 weeks of baseline visit.
- Serum HBV DNA level >10˄7 IU/mL on at least two occasions at least 12 weeks apart during the 52 weeks before baseline visit. One of the two HBV DNA levels must be within 6 weeks of baseline visit.
- ALT levels persistently ≤45 U/L in males, ≤30 U/L in females (approx. 1.5 times the upper limit of normal (ULN) range) as documented by at least three values: one taken 28-52 weeks before baseline visit, one taken 6 to 24 weeks before the baseline visit, & the final value within 6 weeks prior to baseline visit.
- No evidence of hepatocellular carcinoma (HCC) based upon alpha-fetoprotein (AFP) ≤20 ng/mL at screening visit (up to 6 weeks prior to baseline visit). a. Participants who meet American Association for the Study of Liver Diseases (AASLD) criteria for HCC surveillance must have negative liver imaging as shown by ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI) within 28 weeks prior to baseline visit. b. Participants with AFP >20 ng/mL must be evaluated clinically with additional imaging & shown not to have HCC on CT or MRI before they can be enrolled.
Exclusion Criteria:
- History of hepatic decompensation
- Evidence of decompensated liver disease prior to or during screening, including direct bilirubin >0.5 mg/dL, international normalization ratio (INR) >1.5, or serum albumin <3.5 g/dL.
- Platelet count <120,000/mm3, hemoglobin <13 g/dL (males) or <12 g/dL (females), absolute neutrophil count < 1500 /mm3 (<1000/mm3 for African-Americans) at last screening visit.
- Previous treatment with medications that have established activity against HBV including interferon & nucleos(t)ide analogs ≥24 weeks. Patients with <24 weeks of prior HBV treatment & a wash-out period >24 weeks are not excluded.
- Known allergy or intolerance to study medications.
- Females who are pregnant or breastfeeding. Females of childbearing potential unable or unwilling to use a reliable method of contraception during the treatment period.
- Renal insufficiency with calculated creatinine clearance <50 mL/min at screening.
- History of alcohol or drug abuse within 48 weeks of baseline visit.
- Previous liver or other organ transplantation (including engrafted bone marrow).
- Any other concomitant liver disease, including hepatitis C or D. Non-alcoholic fatty liver disease (NAFLD) with steatosis &/or mild to moderate steatohepatitis is acceptable but NAFLD with severe steatohepatitis is exclusionary.
- Presence of anti-hepatitis D virus (HDV) or anti-hepatitis C virus (HCV) (unless HCV RNA negative) in serum on any occasion in the 144 weeks prior to baseline visit. Presence of anti-HIV (test completed within 6 weeks prior to baseline visit).
- Pre-existing psychiatric condition(s), including, but not limited to: current moderate or severe depression, history of depression requiring hospitalization within the past 10 years, history of suicidal or homicidal attempt within the past 10 years, history of severe psychiatric disorders as determined by a study physician.
- History of immune-mediated or cerebrovascular disease, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, poorly controlled diabetes or uncontrolled seizure disorder, as determined by a study physician.
- Any medical condition that would, in the opinion of a study physician, be predicted to be exacerbated by therapy or that would limit study participation.
- Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study.
- Evidence of active or suspected malignancy, or a history of malignancy within the 144 weeks prior to baseline visit (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).
- Expected need for ongoing use of any antivirals with activity against HBV during the course of the study.
- Concomitant use of complementary or alternative medications purported to have antiviral activity.
- Participation in any other clinical trial involving investigational drugs within 30 days of the baseline visit or intention to participate in another clinical trial involving investigational drugs during participation in this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Peginterferon and entecavir
A combination of 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon.
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Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon 180 µg sq weekly during weeks 9-48 of treatment.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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1인당 연간 심각한 부작용(SAE) 발생률
기간: 첫 치료부터 치료 종료(최대 48주) 및 추적 종료(최대 96주)까지
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발생률은 SAE의 수를 관찰한 사람-년 수로 나눈 값으로 계산되며, 이는 모든 참가자의 치료 시작과 치료 종료 또는 추적 종료 사이의 기간(년)의 합계입니다. - 각각.
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첫 치료부터 치료 종료(최대 48주) 및 추적 종료(최대 96주)까지
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Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL
기간: End of follow-up (up to 96 weeks)
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Lack of data was considered to be treatment failure.
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End of follow-up (up to 96 weeks)
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Incidence of Adverse Events (AEs) Per Person-Year of Observation
기간: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
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The number of AEs includes both AEs and Serious Adverse Events (SAEs).
The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
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From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
HBeAg Seroconversion이 있는 참가자의 비율
기간: 치료 종료(최대 48주)
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치료 종료(최대 48주)
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HBeAg Seroconversion이 있는 참가자의 비율
기간: 추적 종료(최대 96주)
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추적 종료(최대 96주)
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HBsAg 혈청전환 환자의 비율
기간: 치료 종료(최대 48주)
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치료 종료(최대 48주)
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HBsAg 혈청전환 환자의 비율
기간: 추적 종료(최대 96주)
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추적 종료(최대 96주)
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HBV DNA가 ≤1000 IU/mL인 참가자 비율
기간: 치료 종료(최대 48주)
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치료 종료(최대 48주)
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HBV DNA가 ≤1000 IU/mL인 참가자 비율
기간: 추적 종료(최대 96주)
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추적 종료(최대 96주)
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Proportion of Participants With HBeAg Loss
기간: End of treatment (up to 48 weeks)
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End of treatment (up to 48 weeks)
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Proportion of Participants With HBeAg Loss
기간: End of follow-up (up to 96 weeks)
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End of follow-up (up to 96 weeks)
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Proportion of Participants With HBsAg Loss
기간: End of treatment (up to 48 weeks)
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End of treatment (up to 48 weeks)
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Proportion of Participants With HBsAg Loss
기간: End of follow-up (up to 96 weeks)
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End of follow-up (up to 96 weeks)
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Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women
기간: End of treatment (up to 48 weeks)
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End of treatment (up to 48 weeks)
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Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women
기간: End of follow-up (up to 96 weeks)
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End of follow-up (up to 96 weeks)
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Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
기간: End of treatment (up to 48 weeks)
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End of treatment (up to 48 weeks)
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Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
기간: End of follow-up (up to 96 weeks)
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End of follow-up (up to 96 weeks)
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Proportion of Participants With HBV DNA <20 IU/mL
기간: End of treatment (up to 48 weeks)
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End of treatment (up to 48 weeks)
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Proportion of Participants With HBV DNA <20 IU/mL
기간: End of follow-up (up to 96 weeks)
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End of follow-up (up to 96 weeks)
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Absence of Detectable Antiviral Drug-resistance HBV Mutations
기간: End of treatment (up to 48 weeks)
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HBV drug resistance variant testing was performed at the CDC laboratory.
The sequences of the HBV polymerase spanning nucleotide positions 311-1021 were determined by Sanger sequencing.
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.
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End of treatment (up to 48 weeks)
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공동 작업자 및 조사자
수사관
- 연구 의자: Averell Sherker, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- 수석 연구원: Anna Lok, MD, University of Michigan
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- DK082864 HBRN IT Adult Trial
- UL1RR024986 (미국 NIH 보조금/계약)
- UL1TR001111 (미국 NIH 보조금/계약)
- U01DK082916 (미국 NIH 보조금/계약)
- U01DK082864 (미국 NIH 보조금/계약)
- U01DK082874 (미국 NIH 보조금/계약)
- U01DK082944 (미국 NIH 보조금/계약)
- U01DK082843 (미국 NIH 보조금/계약)
- U01DK082871 (미국 NIH 보조금/계약)
- UL1TR000004 (미국 NIH 보조금/계약)
- A-DK-3002-001 (기타 보조금/기금 번호: Interagency agreement with NIDDK)
- U01DK082863 (미국 NIH 보조금/계약)
- U01DK082866 (미국 NIH 보조금/계약)
- U01DK082867 (미국 NIH 보조금/계약)
- U01DK082872 (미국 NIH 보조금/계약)
- U01DK082919 (미국 NIH 보조금/계약)
- U01DK082923 (미국 NIH 보조금/계약)
- U01DK082927 (미국 NIH 보조금/계약)
- U01DK082943 (미국 NIH 보조금/계약)
- UL1TR000058 (미국 NIH 보조금/계약)
- P30DK050306 (미국 NIH 보조금/계약)
- M01RR000040 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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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