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Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

20. april 2017 opdateret af: Gilead Sciences

Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy

This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

54

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Vancouver ID Research and Care Centre Society
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • University of California Los Angeles
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center for Liver Diseases and Transplantation
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford University
      • San Francisco, California, Forenede Stater, 94143
        • University of California at San Francisco Medical Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School of Medicine
    • District of Columbia
      • Washington, D.C., District of Columbia, Forenede Stater, 20007
        • Georgetown University Hospital
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Jackson Memorial Hospital
      • Orlando, Florida, Forenede Stater, 32804
        • Florida Hospital Transplant
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63104
        • Saint Louis University Hospital
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegent Creighton Health
    • New York
      • New York, New York, Forenede Stater, 10029
        • Icahn School of Medicine at Mount Sinai
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38104
        • Methodist University Hospital
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Baylor All Saints Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • The Methodist Hospital
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23249
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • Harborview Medical Center

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

Adult participants with chronic HBV infection receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy and with decompensated liver disease at time of consent.

Beskrivelse

Key Inclusion Criteria:

  • Estimated glomerular filtration rate (Cockcroft-Gault method)using actual body weight of ≥ 50 mL/min at time of entry into registry
  • Negative serologies for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV)
  • No history of solid organ or bone marrow transplant
  • Currently receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy within 6 months of inclusion into registry

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Participants with chronic HBV infection
Participants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study.
Medicin: Anti-HBV nucleoside/nucleotide therapy
Subjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade
Tidsramme: Baseline to Year 5
The proportion of participants with a confirmed increase in serum creatinine of at least one grade will be calculated as the number of participants with at least one grade increase in serum creatinine from baseline divided by the total number of subjects enrolled over the 4 years of accrual.
Baseline to Year 5

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade evaluated using the competing risk cumulative incidence framework
Tidsramme: Baseline to Year 5
Baseline to Year 5
Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min
Tidsramme: Baseline to Year 5
Baseline to Year 5
Change in eGFR compared to eGFR at baseline by visit window
Tidsramme: Baseline to Year 5
Baseline to Year 5
Proportion of participants who received appropriate dosing relative to renal function
Tidsramme: Baseline to Year 5
Baseline to Year 5
Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event
Tidsramme: Baseline to Year 5
Baseline to Year 5
Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline
Tidsramme: Baseline to Year 5
Baseline to Year 5
Change in MELD score and liver disease status compared to MELD score at baseline by visit window
Tidsramme: Baseline to Year 5
Baseline to Year 5
Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL)
Tidsramme: Baseline to Year 5
Baseline to Year 5
The median number of renal related adverse events per participant over the evaluation period
Tidsramme: Baseline to Year 5
Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term.
Baseline to Year 5

Samarbejdspartnere og efterforskere

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

Sponsor

Gilead Sciences

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)

26. april 2012

Primær færdiggørelse (Faktiske)

4. april 2017

Studieafslutning (Faktiske)

4. april 2017

Datoer for studieregistrering

Først indsendt

20. marts 2012

Først indsendt, der opfyldte QC-kriterier

2. maj 2012

Først opslået (Skøn)

3. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GX-US-174-0172

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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 .

Kliniske forsøg med Hepatitis B

Kliniske forsøg med Anti-HBV nucleoside/nucleotide therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner