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3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection

10. marts 2017 opdateret af: Janssen R&D Ireland

A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each patients will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of hepatitis C virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last post-therapy follow-up visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

249

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Antwerpen, Belgien
      • Brugge, Belgien
      • Brussels, Belgien
      • Gent, Belgien
      • Leuven, Belgien
  • Canada
      • Montreal, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
      • Nizhny Novgorod, Den Russiske Føderation
      • Saint-Petersburg, Den Russiske Føderation
      • Samara, Den Russiske Føderation
      • Smolensk, Den Russiske Føderation
      • St Petersburg, Den Russiske Føderation
      • Stavropol, Den Russiske Føderation
  • Forenede Stater
    • California
      • Bakersfield, California, Forenede Stater
      • La Jolla, California, Forenede Stater
      • Los Angeles, California, Forenede Stater
    • Florida
      • Jacksonville, Florida, Forenede Stater
      • Orlando, Florida, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater
    • Minnesota
      • Saint Paul, Minnesota, Forenede Stater
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
    • Texas
      • San Antonio, Texas, Forenede Stater
  • Frankrig
      • Creteil, Frankrig
      • Grenoble, Frankrig
      • Lyon, Frankrig
      • Nice N/A, Frankrig
      • Paris, Frankrig
      • Vandoeuvre-Les-Nancy, Frankrig
  • Polen
      • Bialystok, Polen
      • Bydgoszcz, Polen
      • Czeladz, Polen
      • Myslowice, Polen
      • Warszawa, Polen
  • Tyskland
      • Berlin, Tyskland
      • Düsseldorf, Tyskland
      • Frankfurt A. M., Tyskland
      • Freiburg, Tyskland
      • Hamburg, Tyskland
      • Hannover, Tyskland
      • Kiel, Tyskland
      • Köln, Tyskland
      • Würzburg, Tyskland

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

Beskrivelse

Inclusion Criteria:

  • Have previously participated in a Phase IIb or Phase III study
  • Must have received at least one dose of TMC435 in that study
  • Has completed the last post-therapy follow-up visit of the previous (LPVPS) study

Exclusion Criteria:

  • Must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device
  • Have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis C virus (HCV) between LPVPS and the screening visit of present study

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Group 1: TMC 435 - Patients With SVR at LPVPS
Patients with sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) [Phase IIb or Phase III] in which they received a TMC435-containing regimen for the treatment of HCV infection.
Medicin: No treatment
No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.
Andet: Group 2: TMC 435 - Patients With No SVR at LPVPS
Patients with no sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) [Phase IIb or Phase III] in which they received a TMC435-containing regimen for the treatment of HCV infection.
Medicin: No treatment
No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Maintaining SVR at the Last Available Visit
Tidsramme: Last Available Visit (Month 36 for subjects completing the study)
The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).
Last Available Visit (Month 36 for subjects completing the study)
Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study
Tidsramme: Baseline and Month 36
Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Baseline and Month 36
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study
Tidsramme: Baseline and Month 36
Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Baseline and Month 36
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study
Tidsramme: Baseline and Month 36
Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Baseline and Month 36

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Late Viral Relapse
Tidsramme: End of study (at month 36)
Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.
End of study (at month 36)
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Tidsramme: End of study (at month 36)
End of study (at month 36)

Samarbejdspartnere og efterforskere

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

Sponsor

Janssen R&D Ireland

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 (Faktiske)

4. juli 2011

Primær færdiggørelse (Faktiske)

5. januar 2016

Studieafslutning (Faktiske)

5. januar 2016

Datoer for studieregistrering

Først indsendt

26. april 2011

Først indsendt, der opfyldte QC-kriterier

5. maj 2011

Først opslået (Skøn)

6. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR017365
  • TMC435HPC3002 (Anden identifikator: Janssen R&D Ireland)
  • 2010-019843-20 (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 Hepatitis C

Kliniske forsøg med No treatment

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner