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A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)

18. oktober 2018 opdateret af: Qin Ning

A Prospective, Multicentre Observational Follow-up Study of PegIFN Treatment Sustained Response in Nucleoside Experienced Patients With Chronic Hepatitis B (the OCEAN Study)

This is a prospective, multicentre observational follow-up study of PegIFN treatment unstained response in nucleoside experienced patients with Chronic Hepatitis B.Patients will join this study after finished following clinical trail about A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B(OSST trail),A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B (COST study), Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients(Endeavor study),A Prospective Clinical Trial in Chronic Hepatitis B Patients Nucleotide Analogues Experienced (Anchor A Study),Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients (NPGV study).We plan to compare the HBsAg negative rate and maintenance rate,the occurrence of liver cirrhosis and the occurrence rate of hepatocellular carcinoma(HCC) related to hepatitis B virus(HBV) within five years between interferon group (including interferon alone or interferon combined with other drugs) and nucleoside analogues.Patients were divided into two groups based on whether they received interferon or not.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor NPGV studies, were included in the observational study after they finished. The patients entered the following two observation groups based on previous studies: Group A: formerly interferon group (including interferon alone or interferon combined with other drugs); Group B: formerly nucleoside analogue treatment group. Each group was followed for five years.All patients were followed up for physical examination (vital signs, whole body examination) and laboratory assessment (HBsAg quantification, HBeAg quantification, HBV DNA, HBV immunology marker, blood routine, blood biochemistry, alpha fetoprotein, Fibroscan, liver Doppler) in every six month.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina
        • Rekruttering
        • Beijing Youan Hospital, Capital Medical University
        • Kontakt:
          • Chen Xinyue, Doctor
    • Fujian
      • Fuzhou, Fujian, Kina
        • Rekruttering
        • The First Affiliated Hospital of Fujian Medical University
        • Kontakt:
          • Jiang Jiaji, Doctor
    • Guangxi
      • Nanning, Guangxi, Kina
        • Rekruttering
        • The First Affiliated Hospital of Guangxi Medical University
    • Hangzhou
      • Zhejiang, Hangzhou, Kina, Doctor
        • Rekruttering
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
        • Kontakt:
          • Qi Xia
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Rekruttering
        • Tongji Hospital
        • Kontakt:
        • Kontakt:
    • Hunan
      • Changsha, Hunan, Kina
        • Rekruttering
        • Departmen of infectious disease, Xiangya Hospital, Central-south Universit
        • Kontakt:
          • Tan Deming, Doctor
      • Changsha, Hunan, Kina
        • Rekruttering
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Rekruttering
        • The First Affiliated Hospital with Nanjing Medical University
      • Nanjing, Jiangsu, Kina
        • Rekruttering
        • The Second Hospital of Nanjing
    • Xiamen
      • Shantou, Xiamen, Kina
        • Rekruttering
        • Traditional Chinese Medicine,Xiamen Hospital
    • Zhejiang
      • Wenzhou, Zhejiang, Kina
        • Rekruttering
        • The first affiliated hospital of Wenzhou medical universtiy
        • Kontakt:
          • Chen Yongping, Doctor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor,NPGV studies, were included in the observational study after they finished.

Beskrivelse

Inclusion Criteria:

  1. Male and female patients from 18 to 65 years of age;
  2. Have finished the OSST,COST,Endeavor, Anchor,NPGV studies;
  3. Agree to participate in the study and sign the patient informed consent.

Exclusion Criteria:

  1. patients have not participated in the OSST,Cost,Endeavor,Anchor or NPGV study ;
  2. unable or unwilling to provide informed consent or follow the research requirements

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Group A: interferon group
formerly interferon group (including interferon alone or interferon combined with other drugs)
Group B:nucleoside analogue group
formerly nucleoside analogue treatment group. Each group was followed for five years

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The rate of HBsAg negative at week 260
Tidsramme: week 260
Compare the HBsAg negative rate at week 260 with that at baseline
week 260

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The maintenance response rate of HBsAg negativity at week 260
Tidsramme: week 260
the proportion of patients with sustained HBsAg negativity at week 260 among the patients whose HBsAg negative at baseline
week 260
HBsAg quantification decline from baseline to week 260
Tidsramme: week 260
HBsAg quantification decline from baseline to week 260 are measured.
week 260
Change from baseline in HBsAg seroconversion at week 260
Tidsramme: week 260
HBsAg seroconversion from baseline is measured
week 260
The rate of HBsAb positive at week 260
Tidsramme: week 260
Compare the rate of HBsAb positive at week 260 with that at baseline
week 260
Measure the Fibroscan value
Tidsramme: week 260
Fibroscan value from baseline is measured
week 260
the occurrence rate of liver cirrhosis
Tidsramme: week 260
Statistics for occurrence rates of liver cirrhosis
week 260
the occurrence rate of HCC related to HBV
Tidsramme: week 260
Statistics for occurrence rates of HCC related to HBV
week 260
The proportion of patients with HBV DNA <1000 copies / mL
Tidsramme: week 260
Statistics the proportion of patients with HBV DNA <1000 copies / mL
week 260

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qin Ning

Efterforskere

  • Ledende efterforsker: Ning Qin, Doctor, Department of infectious Diseases, Tongji Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. februar 2018

Primær færdiggørelse (Forventet)

1. december 2020

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

20. november 2017

Først indsendt, der opfyldte QC-kriterier

29. november 2017

Først opslået (Faktiske)

30. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OCEAN study

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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