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

24. september 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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 .

Studietype

Intervensjonell

Registrering (Faktiske)

719

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: PEG-IFN-SA /RBV
Aktiv komparator: 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
Legemiddel: Pegasys /RBV
Eksperimentell: 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
Legemiddel: PEG-IFN-SA /RBV
Aktiv komparator: 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
Legemiddel: Pegasys /RBV

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
SVR (sustained virologic response)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
RVR(rapid virologic response)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beijing Kawin Technology Share-Holding Co., Ltd.

Etterforskere

  • Hovedetterforsker: Cheng jun, MD, PhD, Beijing Ditan Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2013

Primær fullføring (Faktiske)

1. august 2015

Studiet fullført (Faktiske)

1. august 2015

Datoer for studieregistrering

Først innsendt

17. juli 2013

Først innsendt som oppfylte QC-kriteriene

17. juli 2013

Først lagt ut (Anslag)

19. juli 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. september 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KAWIN-002-2

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