- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05086536
Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
7. oktober 2021 oppdatert av: Hong You, Beijing Friendship Hospital
Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage).
Patients were followed up every 6 months until death /liver transplantation or for 5 years.
Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected.
In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage).
Patients were followed up every 6 months until death /liver transplantation or for 5 years.
WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected.
This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.
Studietype
Observasjonsmessig
Registrering (Forventet)
600
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hong You, Doctor
- Telefonnummer: 861063139019
- E-post: youhong30@sina.com
Studer Kontakt Backup
- Navn: Jialing Zhou, Master
- Telefonnummer: 010-63138665
- E-post: zhoujialing11@126.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100050
- Beijing Friendship Hospital, Capital Medical University
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Hovedetterforsker:
- Hong You, Doctor
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Ta kontakt med:
- Xiaoning Wu, Doctor
- Telefonnummer: 8610-63138665
- E-post: wuxiaoningbs@126.com
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Ta kontakt med:
- Zhiying He
- Telefonnummer: 13311314386
- E-post: zhiyinghe2012@126.com
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Beijing, Beijing, Kina, 10069
- Beijing Youan Hospital, Capital Medical University
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Ta kontakt med:
- Jie Chen, Doctor
- Telefonnummer: 13810594713
- E-post: jiechenokcat0215@126.com
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Hovedetterforsker:
- Zhongjie Hu
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Hunan
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Changsha, Hunan, Kina, 410011
- Xiangya Hospital Central South University
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Ta kontakt med:
- Yixiang Zheng, Doctor
- Telefonnummer: 15111002627
- E-post: 418414718@qq.com
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Inner Mongolia
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Baotou, Inner Mongolia, Kina
- The Second Affiliated Hospital of Baotou Medical Coll
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Shandong
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Jinan, Shandong, Kina, 250021
- Shandong Provincial Hospital
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Ta kontakt med:
- Lianhui Zhao, Doctor
- Telefonnummer: 18810825004
- E-post: 18253163004@163.com
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Hovedetterforsker:
- Chunqing Zhang, Docote
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Qingdao, Shandong, Kina, 266000
- The Affiliated Hospital Of Qingdao University
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Ta kontakt med:
- Qiuju Tian, Doctor
- Telefonnummer: 18610827822
- E-post: tianqiuju_1017@163.com
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Hovedetterforsker:
- Wei Rao, Docotr
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Shanxi
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Taiyuan, Shanxi, Kina, 030001
- First Hospital Of ShanXi Medical University
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Ta kontakt med:
- Yanqin Hao, Doctor
- Telefonnummer: 13994262902
- E-post: 13994262902@163.com
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Hovedetterforsker:
- Yanqin Hao, Doctor
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Hovedetterforsker:
- Liaoyun Zhang, Doctor
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
HBV-decompensated cirrhosis patients who occurred first decompensated events and initiated antiviral therapy within 3 months.
Beskrivelse
Inclusion Criteria:
- Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
- Initiating antiviral therapy within 3 months of the first decompensated events;
- Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
Clinical outcomes were classified:
- Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
- With ≥ 2 episodes of decompensation: medical records for decompensation were available.
Exclusion Criteria:
- Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
- Liver transplantation /death within 6 months of first decompensated events;
- complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
- Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
- Pregnant women.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
early stage decompensation cohort
Patients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included.
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This is a retrospective and observational study.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cumulative incidence of re-compensation
Tidsramme: Year 5
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Patients who did not occur further decompensation
|
Year 5
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cumulative incidence of re-compensation
Tidsramme: Year 1, 2, 3, and 4
|
Patients who did not occur further decompensation
|
Year 1, 2, 3, and 4
|
Annual incidence of second decompensation
Tidsramme: Year 1, 2, 3, 4, and 5
|
Patients who occurred second decompensation
|
Year 1, 2, 3, 4, and 5
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Cumulative incidence of liver-related death / liver transplantation
Tidsramme: Year 1, 2, 3, 4, and 5
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Patients who died of decompensation
|
Year 1, 2, 3, 4, and 5
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Cumulative incidence of HCC
Tidsramme: Year 1, 2, 3, 4, and 5
|
Patients who occurred HCC
|
Year 1, 2, 3, 4, and 5
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Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group
Tidsramme: Year 1, 2, 3, 4, and 5
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Child-Pugh
|
Year 1, 2, 3, 4, and 5
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Dynamic changes of MELD score in re-compensated and not re-compensated group
Tidsramme: Year 1, 2, 3, 4, and 5
|
MELD
|
Year 1, 2, 3, 4, and 5
|
Dynamic changes of APRI score in re-compensated and not re-compensated group
Tidsramme: Year 1, 2, 3, 4, and 5
|
APRI
|
Year 1, 2, 3, 4, and 5
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Dynamic changes of FIB-4 score in re-compensated and not re-compensated group
Tidsramme: Year 1, 2, 3, 4, and 5
|
FIB-4
|
Year 1, 2, 3, 4, and 5
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Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group
Tidsramme: Year 1, 2, 3, 4, and 5
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Liver stiffness
|
Year 1, 2, 3, 4, and 5
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hong You, Doctor, Beijing Friendship Hospita
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Jang JW, Choi JY, Kim YS, Woo HY, Choi SK, Lee CH, Kim TY, Sohn JH, Tak WY, Han KH. Long-term effect of antiviral therapy on disease course after decompensation in patients with hepatitis B virus-related cirrhosis. Hepatology. 2015 Jun;61(6):1809-20. doi: 10.1002/hep.27723. Epub 2015 Mar 18.
- Belli LS, Berenguer M, Cortesi PA, Strazzabosco M, Rockenschaub SR, Martini S, Morelli C, Donato F, Volpes R, Pageaux GP, Coilly A, Fagiuoli S, Amaddeo G, Perricone G, Vinaixa C, Berlakovich G, Facchetti R, Polak W, Muiesan P, Duvoux C; European Liver and Intestine Association (ELITA). Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study. J Hepatol. 2016 Sep;65(3):524-31. doi: 10.1016/j.jhep.2016.05.010. Epub 2016 May 17.
- Pascasio JM, Vinaixa C, Ferrer MT, Colmenero J, Rubin A, Castells L, Manzano ML, Lorente S, Testillano M, Xiol X, Molina E, Gonzalez-Dieguez L, Oton E, Pascual S, Santos B, Herrero JI, Salcedo M, Montero JL, Sanchez-Antolin G, Narvaez I, Nogueras F, Giraldez A, Prieto M, Forns X, Londono MC. Clinical outcomes of patients undergoing antiviral therapy while awaiting liver transplantation. J Hepatol. 2017 Dec;67(6):1168-1176. doi: 10.1016/j.jhep.2017.08.008. Epub 2017 Aug 24.
- Perricone G, Duvoux C, Berenguer M, Cortesi PA, Vinaixa C, Facchetti R, Mazzarelli C, Rockenschaub SR, Martini S, Morelli C, Monico S, Volpes R, Pageaux GP, Fagiuoli S, Belli LS; European Liver and Intestine Transplant Association (ELITA). Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting. Liver Int. 2018 Dec;38(12):2170-2177. doi: 10.1111/liv.13878. Epub 2018 May 25.
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 (Forventet)
15. oktober 2021
Primær fullføring (Forventet)
1. juni 2022
Studiet fullført (Forventet)
30. desember 2022
Datoer for studieregistrering
Først innsendt
19. september 2021
Først innsendt som oppfylte QC-kriteriene
7. oktober 2021
Først lagt ut (Faktiske)
21. oktober 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. oktober 2021
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2021-P2-224-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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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