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

18. oktober 2018 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Forventet)

1600

Kontakter og plasseringer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina
        • Rekruttering
        • Beijing Youan Hospital, Capital Medical University
        • Ta kontakt med:
          • Chen Xinyue, Doctor
    • Fujian
      • Fuzhou, Fujian, Kina
        • Rekruttering
        • The First Affiliated Hospital of Fujian Medical University
        • Ta kontakt med:
          • 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
        • Ta kontakt med:
          • Qi Xia
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Rekruttering
        • Tongji Hospital
        • Ta kontakt med:
        • Ta kontakt med:
    • Hunan
      • Changsha, Hunan, Kina
        • Rekruttering
        • Departmen of infectious disease, Xiangya Hospital, Central-south Universit
        • Ta kontakt med:
          • 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
        • Ta kontakt med:
          • Chen Yongping, Doctor

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Control
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Qin Ning

Etterforskere

  • Hovedetterforsker: Ning Qin, Doctor, Department of infectious Diseases, Tongji 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 (Faktiske)

27. februar 2018

Primær fullføring (Forventet)

1. desember 2020

Studiet fullført (Forventet)

1. desember 2022

Datoer for studieregistrering

Først innsendt

20. november 2017

Først innsendt som oppfylte QC-kriteriene

29. november 2017

Først lagt ut (Faktiske)

30. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • OCEAN study

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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