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Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection

29. september 2017 opdateret af: Gilead Sciences

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection

This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

241

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien
        • Royal Prince Alfred Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Gordon and Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada
        • Liver and Intestinal Research Centre
    • Manitoba
      • Winnepeg, Manitoba, Canada
        • University of Manitoba
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto General Hospital
  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater
        • Kaiser Permanente
      • San Diego, California, Forenede Stater
        • Kaiser Permanente
      • San Francisco, California, Forenede Stater
        • Kaiser Permanente
      • San Jose, California, Forenede Stater
        • Silicon Valley Research Institute
    • Florida
      • Miami, Florida, Forenede Stater
        • University of Miami
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • Digestive Disease Associates, PA
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
        • University of Michigan
      • Detroit, Michigan, Forenede Stater
        • Henry Ford Hospital
    • Missouri
      • Saint Louis, Missouri, Forenede Stater
        • St. Louis University
    • New York
      • Flushing, New York, Forenede Stater
        • Medical Procare, PLL
      • Manhasset, New York, Forenede Stater
        • Northwell Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater
        • Xiaoli Ma, PC
    • Virginia
      • Newport News, Virginia, Forenede Stater
        • Bon Secours St. Mary's Hospital of Richmond
  • Hong Kong
      • Lai Chi Kok, Hong Kong
        • Princess Margaret Hospital
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital
  • Indien
    • Gurarat
      • Surat, Gurarat, Indien
        • Nirmal Hospital Private Limited
    • Maharashtra
      • Nagpur, Maharashtra, Indien
        • Midas Multispecialty Hospital Private Limited
    • West Bengal
      • Kolkata, West Bengal, Indien
        • Dept. of Hepatology, School of Digestive & Liver Diseases
  • Italien
      • Milano, Italien
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Parma, Italien
        • Azienda Ospedaliera Universitaria di Parma
    • Foggia
      • San Giovanni Rotondo, Foggia, Italien
        • IRCCS Ospedale Casa Sollievo della Sofferenza
    • Pisa
      • Caianello, Pisa, Italien
        • Azienda Ospedaliera Universitaria Pisana
  • Korea, Republikken
      • Busan, Korea, Republikken
        • Pusan National
      • Seoul, Korea, Republikken
        • Samsung Medical Center
      • Seoul, Korea, Republikken
        • Yonsei University
      • Seoul, Korea, Republikken
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republikken
        • Korea University
  • New Zealand
      • Auckland, New Zealand
        • Auckland City 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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.

Beskrivelse

Key Inclusion Criteria:

  • Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol.
  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Must be willing and able to comply with the visit schedule and study requirements
  • Must have documented HBV DNA < 2,000 IU/mL at time of screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
  • Must have documented hepatitis B surface antigen (HBsAg) negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment

Key Exclusion Criteria:

  • Patient participating or planning to participate in another clinical study with an investigational agent
  • History of clinically-significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
  • Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
  • Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48
Tidsramme: Week 48
This endpoint will be measured for participants who are HBsAg positive at baseline.
Week 48
Proportion of participants who remain HBsAg negative at Week 48
Tidsramme: Week 48
This endpoint will be measured for participants who are HBsAg negative at baseline.
Week 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144
Tidsramme: Week 144
This endpoint will be measured for participants who are HBsAg positive at baseline.
Week 144
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144
Tidsramme: Weeks 48, 144
This endpoint will be measured for participants who are HBsAg positive at baseline.
Weeks 48, 144
Proportion of participants who remain HBsAg negative at Week 144
Tidsramme: Week 144
This endpoint will be measured for participants who are HBsAg negative at baseline.
Week 144
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48
Tidsramme: Week 48
This endpoint will be measured for participants who are HBeAg positive at baseline.
Week 48
Proportions of participants with HBeAg loss and seroconversion at Week 144
Tidsramme: Week 144
This endpoint will be measured for participants who are HBeAg positive at baseline.
Week 144
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48
Tidsramme: Week 48
This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Week 48
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144
Tidsramme: Week 144
This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Week 144
Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144
Tidsramme: Weeks 48, 96 and 144
This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.
Weeks 48, 96 and 144
Change from Baseline in HBV DNA at Weeks 48, 96, and 144
Tidsramme: Baseline; Week 48; Week 96; Week 144
Baseline; Week 48; Week 96; Week 144

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)

9. december 2014

Primær færdiggørelse (Faktiske)

14. august 2017

Studieafslutning (Faktiske)

14. august 2017

Datoer for studieregistrering

Først indsendt

3. oktober 2014

Først indsendt, der opfyldte QC-kriterier

3. oktober 2014

Først opslået (Skøn)

7. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GS-US-330-1508
  • 2015-001050-16 (EudraCT nummer)

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

Kliniske forsøg med GS-4774

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Azerbaijan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner