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Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C

2015년 9월 24일 업데이트: Cheng jun, Beijing Kawin Technology Share-Holding Co., Ltd.

Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C

This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Total 720 subjects are divided into two groups and treated separately according to the HCV genotype（genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .

연구 유형

중재적

등록 (실제)

719

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 중국
      • Beijing, 중국
        • Peking University First Hospital
      • Beijing, 중국
        • Beijing Ditan Hospital, Capital Medical University
      • Beijing, 중국
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, 중국
        • Peking University People's Hospital
      • Beijing, 중국
        • 302 Military Hospital of China
      • Beijing, 중국
        • Beijing Youyi Hospital, capital Medical University
      • Beijing, 중국
        • General Hospital of Beijing Military Region
      • Chongqing, 중국
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing, 중국
        • Chongqing Southwest Hospital
      • Shanghai, 중국
        • Shanghai Public Health Clinical Center
      • Tianjin, 중국
        • Tianjin Infectious Disease Hospital
    • Gansu
      • Lanzhou, Gansu, 중국
        • First Affiliated Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, 중국
        • Guangzhou Eighth People's Hospital
      • Guangzhou, Guangdong, 중국
        • Nanfang Hospital Southern Medical Unbiversity
    • Guangxi
      • Nanning, Guangxi, 중국
        • The First Affiliated Hospital of Guangxi Medical University
    • Hebei
      • Shijiazhuang, Hebei, 중국
        • Third Affiliated Hospital, Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, 중국
        • The Second Affiliated Hospital of Harbin Medical University
    • Henan
      • Xinxiang, Henan, 중국
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, 중국
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, 중국
        • Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology
      • Wuhan, Hubei, 중국
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, 중국
        • Union hospital, Tongji Medical College Huazhong University of Science ＆ Technology
    • Hunan
      • Changsha, Hunan, 중국
        • The second Xiangya Hospital of Central South University
      • Changsha, Hunan, 중국
        • Xiangya Hospital Central-South University
    • Jiangsu
      • Nanjing, Jiangsu, 중국
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, 중국
        • The Second Hospital of Nanjing
    • Jiangxi
      • Nanchang, Jiangxi, 중국
        • First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, 중국
        • The first Affiliated Hospital of Jilin University
      • Yanji, Jilin, 중국
        • Yanbian University Hospital (Yanbian Hospital)
    • Liaoning
      • Shenyang, Liaoning, 중국
        • The Sixth People's Hospital of Shenyang
    • Shaanxi
      • Xi'an, Shaanxi, 중국
        • First Affiliated Hospital of Medical College of Xian jiaotong University
      • Xi'an, Shaanxi, 중국
        • Second Affiliated Hospital Of Medical College of Xian Jiaotong University
      • Xi'an, Shaanxi, 중국
        • Tangdu hospital,fourth military medical university
    • Shandong
      • Jinan, Shandong, 중국
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, 중국
        • Jinan Infectious Disease Hospital
      • Qingdao, Shandong, 중국
        • Qingdao Municipal Hospital
    • Shanxi
      • Taiyuan, Shanxi, 중국
        • The First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, 중국
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, 중국
        • Sichuan Academy of Medical Science ＆Sichuan Provincial People's Hospital
    • Xinjiang
      • Urumqi, Xinjiang, 중국
        • The First Teaching Hospital of Xinjiang Medical University
    • Zhejiang
      • Wenzhou, Zhejiang, 중국
        • The First Affiliated Hospital of Wenzhou Medical University

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

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age 18- 65 years
  • Body Mass Index (BMI) 18-30
  • Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)
  • Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody
  • Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment
  • Volunteered to participate in this study, understood and signed an informed consent

Exclusion Criteria:

  • Previous IFN treated patients
  • Hepatotoxic drugs was systematically used more than two weeks within past 6 months
  • Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids
  • Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
  • Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
  • Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP> l00ng/ml, suspicious liver nodules by imaging examinations
  • Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
  • White blood cell count <3×109/L; Neutrophil count<1.5×109/L; platelet count<90×109/L; hemoglobin below the lower limit of normal
  • Serum creatinine above the ULN
  • Serum creatine kinase> 3 ULN
  • Diabetes mellitus or Poorly controlled Thyroid Diseases
  • Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions
  • Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
  • Psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
  • Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias)
  • Serious blood disorders (all kinds of anemia, hemophilia, etc.)
  • Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
  • Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
  • Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
  • Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
  • Malignancies
  • Function organs transplant
  • Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
  • Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day)
  • Pregnant or lactating women
  • Usage of prohibition drugs in this study
  • Participated in other clinical trials 3 months prior to the screening
  • Unwilling to sign the informed consent and adhere to treatment requirements
  • Other conditions not suitable for study judged by investigators

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: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: PEG-IFN-SA /RBV T1(Genotype2,3)
PEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid（BW<75kg,1000mg/d; BW≥75kg, 1200mg/d）,24 weeks
의약품: PEG-IFN-SA /RBV
활성 비교기: Pegasys /RBV C1(Genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 24 weeks
의약품: Pegasys /RBV
실험적: PEG-IFN-SA /RBV T2(Non-genotype 2,3)
PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
의약품: PEG-IFN-SA /RBV
활성 비교기: Pegasys /RBV C2(Non-genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
의약품: Pegasys /RBV

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
SVR (sustained virologic response)
기간: 24 weeks after 24 or 48 weeks of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of treatment
24 weeks after 24 or 48 weeks of study therapy

2차 결과 측정

결과 측정
측정값 설명
기간
RVR(rapid virologic response)
기간: weeks 4 of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4
weeks 4 of study therapy
cEVR (complete early virologic response)
기간: weeks 12 of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 12
weeks 12 of study therapy
ETVR( end of treatment virologic response)
기간: weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at the end of treatment
weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
eRVR ( extended rapid virologic response)
기간: weeks 4 and 12 of study therapy
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 and 12
weeks 4 and 12 of study therapy
No-responses
기간: weeks 12 or weeks 24 of study therapy
defined as the proportion of patients who had less than a <2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24
weeks 12 or weeks 24 of study therapy
Breakthrough
기간: weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)
weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
Relapse
기간: 12 and 24 weeks after 24 or 48 weeks of study therapy
defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then
12 and 24 weeks after 24 or 48 weeks of study therapy

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Kawin Technology Share-Holding Co., Ltd.

수사관

  • 수석 연구원: Cheng jun, MD, PhD, Beijing Ditan Hospital

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

2013년 6월 1일

기본 완료 (실제)

2015년 8월 1일

연구 완료 (실제)

2015년 8월 1일

연구 등록 날짜

최초 제출

2013년 7월 17일

QC 기준을 충족하는 최초 제출

2013년 7월 17일

처음 게시됨 (추정)

2013년 7월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 9월 24일

마지막으로 확인됨

2015년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KAWIN-002-2

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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