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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 oppdatert av: 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).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

241

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • 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
  • Forente stater
    • California
      • Sacramento, California, Forente stater
        • Kaiser Permanente
      • San Diego, California, Forente stater
        • Kaiser Permanente
      • San Francisco, California, Forente stater
        • Kaiser Permanente
      • San Jose, California, Forente stater
        • Silicon Valley Research Institute
    • Florida
      • Miami, Florida, Forente stater
        • University of Miami
    • Hawaii
      • Honolulu, Hawaii, Forente stater
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, Forente stater
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, Forente stater
        • Digestive Disease Associates, PA
    • Massachusetts
      • Boston, Massachusetts, Forente stater
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater
        • University of Michigan
      • Detroit, Michigan, Forente stater
        • Henry Ford Hospital
    • Missouri
      • Saint Louis, Missouri, Forente stater
        • St. Louis University
    • New York
      • Flushing, New York, Forente stater
        • Medical Procare, PLL
      • Manhasset, New York, Forente stater
        • Northwell Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater
        • Xiaoli Ma, PC
    • Virginia
      • Newport News, Virginia, Forente 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
  • India
    • Gurarat
      • Surat, Gurarat, India
        • Nirmal Hospital Private Limited
    • Maharashtra
      • Nagpur, Maharashtra, India
        • Midas Multispecialty Hospital Private Limited
    • West Bengal
      • Kolkata, West Bengal, India
        • Dept. of Hepatology, School of Digestive & Liver Diseases
  • Italia
      • Milano, Italia
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Parma, Italia
        • Azienda Ospedaliera Universitaria di Parma
    • Foggia
      • San Giovanni Rotondo, Foggia, Italia
        • IRCCS Ospedale Casa Sollievo della Sofferenza
    • Pisa
      • Caianello, Pisa, Italia
        • 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

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gilead Sciences

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 (Faktiske)

9. desember 2014

Primær fullføring (Faktiske)

14. august 2017

Studiet fullført (Faktiske)

14. august 2017

Datoer for studieregistrering

Først innsendt

3. oktober 2014

Først innsendt som oppfylte QC-kriteriene

3. oktober 2014

Først lagt ut (Anslag)

7. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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. .

Kliniske studier på Kronisk hepatitt B

Kliniske studier på GS-4774

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Dominican Republic

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere