Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China (EVOLVE)

13. juli 2020 opdateret af: Bristol-Myers Squibb

A 5-year Prospective and Observational Study to Evaluate the Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Chronic Hepatitis B (CHB) Patients Naive to NUC in Real World Practice at Hospitals in Tier 2 Cities in China (the EVOLVE Study)

To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at enrollment to this study

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Sampling Method: Consecutive patient sampling

Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3434

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, 100050
        • Local Institution
    • Chongqing
      • Chongqing, Chongqing, Kina, 400038
        • Local Institution
      • Chongqing, Chongqing, Kina, 710032
        • Local Institution
    • Fujian
      • Fuzhou, Fujian, Kina, 350000
        • Local Institution
      • Quanzhou, Fujian, Kina, 362002
        • Local Institution
      • Xiamen, Fujian, Kina, 1361009
        • Local Institution
    • Guangdong
      • Foshan, Guangdong, Kina, 528000
        • Local Institution
      • Shenzhen, Guangdong, Kina, 528000
        • Local Institution
    • Guangxi
      • Nanning, Guangxi, Kina, 530000
        • Local Institution
    • Guizhou
      • Guiyang, Guizhou, Kina, 550000
        • Local Institution
      • Guiyang, Guizhou, Kina, 55000
        • Local Institution
    • Hainan
      • Haikou, Hainan, Kina, 570100
        • Local Institution
    • Hebei
      • Baoding, Hebei, Kina, 071000
        • Local Institution
      • Shijiazhuang, Hebei, Kina, 050000
        • Local Institution
    • Heilongjiang
      • Daqing, Heilongjiang, Kina, 163461
        • Local Institution
      • Haerbin, Heilongjiang, Kina, 150086
        • Local Institution
    • Henan
      • Zhengzhou, Henan, Kina, 430000
        • Local Institution
      • Zhengzhou, Henan, Kina, 450000
        • Local Institution
    • Hubei
      • Shiyan, Hubei, Kina, 430000
        • Local Institution
      • Wuhan, Hubei, Kina, 430022
        • Local Institution
      • Wuhan, Hubei, Kina, 430032
        • Local Institution
    • Hunan
      • Changsha, Hunan, Kina, 410008
        • Local Institution
      • Changsha, Hunan, Kina, 410006
        • Local Institution
      • Changsha, Hunan, Kina, 410013
        • Local Institution
    • Inner Mongolia
      • Erdos, Inner Mongolia, Kina, 17000
        • Local Institution
    • Jiangsu
      • Changshu, Jiangsu, Kina, 215500
        • Local Institution
      • Changzhou, Jiangsu, Kina, 213001
        • Local Institution
      • Nanjing, Jiangsu, Kina, 210000
        • Local Institution
      • Suzhou, Jiangsu, Kina, 215000
        • Local Institution
    • Jiangxi
      • Nangchang, Jiangxi, Kina, 330006
        • Local Institution
    • Jilin
      • Changchun, Jilin, Kina, 130000
        • Local Institution
      • Yanji, Jilin, Kina, 133000
        • Local Institution
    • Liaoning
      • Dalian, Liaoning, Kina, 116001
        • Local Institution
      • Fushun, Liaoning, Kina, 113000
        • Local Instution
      • Shengyang, Liaoning, Kina
        • Local Institution
      • Shenyang, Liaoning, Kina, 110006
        • Local Institution
    • Ningxia
      • Yinchuan, Ningxia, Kina, 750000
        • Local Institution
    • Shandong
      • Jinan, Shandong, Kina, 250000
        • Local Institution
      • Qingdao, Shandong, Kina, 266000
        • Local Institution
      • Yantai, Shandong, Kina, 264001
        • Local Institution
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030000
        • Local Institution
      • Taiyuan, Shanxi, Kina, 30000
        • Local Institution
      • Xi'an, Shanxi, Kina, 710032
        • Local Institution
      • Xi'an, Shanxi, Kina, 710061
        • Local Institution
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Local Institution
      • Chengdu, Sichuan, Kina, 610072
        • Local Institution
    • Tianjin
      • Tianjin, Tianjin, Kina, 300000
        • Local Institution
    • Xinjiang
      • Urumqi, Xinjiang, Kina, 830001
        • Local Institution
      • Wulumuqi, Xinjiang, Kina, 830001
        • Local Institution
      • Wulumuqi, Xinjiang, Kina, 830052
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • Local Institution
      • Hangzhou, Zhejiang, Kina, 310006
        • Local Institution
      • Hangzhou, Zhejiang, Kina, 310023
        • Local Institution
      • Jinghua, Zhejiang, Kina, 300000
        • Local Institution
      • Ningbo, Zhejiang, Kina, 315010
        • Local Institution

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Hospitals in Chinese tier 2 cities. The definition of these hospitals is the following:

  • Hospitals where 300 or more CHB patients are treated monthly
  • Hospitals where PCR can be performed in the hospital's laboratory to measure HBV DNA serum levels

Beskrivelse

Inclusion Criteria:

  • CHB patients, or CHB patients with compensated cirrhosis, as defined by the current Chinese guidelines
  • Male or female
  • ≥ 18 years of age
  • Either Hepatitis B e antigen (HBeAg) positive or negative
  • Naïve to NUC (defined as no previous exposure to NUC treatment as based on patient self-report)
  • Has compensated liver disease
  • Patients with compensated cirrhosis
  • Patients who consent to participate in this study
  • Local residents with medical reimbursement coverage preferred

Exclusion Criteria:

  • Co-infected with hepatitis C virus (HCV)
  • CHB patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or any other types of malignancy at the screening phase
  • CHB patients who are being treated by interferon therapy within 6 months immediately prior to the screening phase of this study
  • CHB patients with a confirmed pregnancy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
CHB patients who are naive to NUC treatment
CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy
Tidsramme: 48 weeks after initial NUC antiviral therapy
Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) < 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory
48 weeks after initial NUC antiviral therapy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups)
Tidsramme: Baseline (Day 1) and 48 weeks
Baseline (Day 1) and 48 weeks
Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups)
Tidsramme: 24 weeks and 96 weeks
24 weeks and 96 weeks
Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options
Tidsramme: 24 weeks, 48 weeks and 96 weeks
24 weeks, 48 weeks and 96 weeks
Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment
Tidsramme: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory
24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance
Tidsramme: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms
Tidsramme: 48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. december 2012

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Faktiske)

31. december 2018

Datoer for studieregistrering

Først indsendt

6. november 2012

Først indsendt, der opfyldte QC-kriterier

14. november 2012

Først opslået (Skøn)

15. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI463-952

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med Kronisk hepatitis B

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Hungary

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner