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Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Chronic HBV Infection

23. juli 2019 opdateret af: Yao Xie, Beijing Ditan Hospital

Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Patients With Chronic HBV Infection

This study is a retrospective study. Enrollment study. Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection. The data collected included patient gender, . The data collected included patient gender, . The data collected included the patient's gender, age, HBV age of infection, past family history, etc., the age of the collected subjects, the current family history, etc., the liver histopathological diagnosis information collected in the group, and the liver disease examination Clinical toxicities and indicators, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serum HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe content, biochemical indicators coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Observe patient demographic data, HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe HBe content, biochemical indicators, coagulation Correlation between function and routine, coagulation function and conventional indicators and liver histological changes. Explore the relevance of effective diagnosis of liver changes. To explore the characteristics of clinical indicators that can effectively diagnose liver histopathological changes, and to provide clinical indicators for patients with chronic hepatitis B to receive timely treatment of histopathological changes, and provide important evidence for patients with chronic hepatitis B to receive timely treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a retrospective study. Enrollment study. Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection. The data collected included patient gender, . The data collected included patient gender, . The data collected included the patient's gender, age, HBV age of infection, past family history, etc., the age of the collected subjects, the current family history, etc., the liver histopathological diagnosis information collected in the group, and the liver disease examination Clinical toxicities and indicators, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serum HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe content, biochemical indicators coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Observe patient demographic data, HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe HBe content, biochemical indicators, coagulation Correlation between function and routine, coagulation function and conventional indicators and liver histological changes. Explore the relevance of effective diagnosis of liver changes. To explore the characteristics of clinical indicators that can effectively diagnose liver histopathological changes, and to provide clinical indicators for patients with chronic hepatitis B to receive timely treatment of histopathological changes, and provide important evidence for patients with chronic hepatitis B to receive timely treatment.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

400

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, 100015
        • liver disease center, Beijing Ditan Hospital

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

Sandsynlighedsprøve

Studiebefolkning

Patients with chronic HBVHBVHBV infection: all meet the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (: all meet the diagnostic criteria for the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015), HBsAg HBsAg HBsAg positive for 6 months Month;

Beskrivelse

Inclusion Criteria:

  • 1) Age between 18 and over 65;
  • 2) gender is not limited;
  • 3) Patients with chronic HBVHBVHBV infection: all meet the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (: all meet the diagnostic criteria for the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015), HBsAg HBsAg HBsAg positive for 6 months Month;
  • 4) Sign the written informed consent.Exclusion Criteria:

Exclusion Criteria:

  • 1) Combine other hepatitis viruses (HCV (HCV, HDV, HDV) infection;
  • 2) autoimmune liver disease;
  • 3) HIVHIV HIV infection;
  • 4) long-term alcohol abuse and / or other liver damage drugs;
  • 5) mental illness;
  • 6) Evidence of liver tumors (cancer or AFP AFP>100 ng/ml 100 ng/ml 100 ng/ml 100 ng/ml);
  • 7) decompensated cirrhosis.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Untreated chronic HBV infected person group
Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection.
Andet: Chronic hepatitis B infection
Chronic hepatitis B infection patients

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the diagnostic ability of clinical indicators
Tidsramme: 6 months
Clinical indicators characterize the diagnostic ability of liver histology inflammation and fibrosis
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Beijing Ditan Hospital

Efterforskere

  • Ledende efterforsker: Yao Xie, Doctor, Beijing Ditan Hospital, Beijing, China

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)

1. januar 2018

Primær færdiggørelse (Faktiske)

30. december 2018

Studieafslutning (Faktiske)

30. december 2018

Datoer for studieregistrering

Først indsendt

20. juli 2019

Først indsendt, der opfyldte QC-kriterier

23. juli 2019

Først opslået (Faktiske)

25. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DTXY020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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