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An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

18. oktober 2016 opdateret af: Hoffmann-La Roche

Non-interventional Study to Observe Triple Combination Therapy With Boceprevir or Simeprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary (IMPERIAL)

This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

19

Kontakter og lokationer

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

Studiesteder

  • Ungarn
      • Budapest, Ungarn, 1125
      • Budapest, Ungarn, 1097
      • Békéscsaba, Ungarn, 5600
      • Debrecen, Ungarn, 4032
      • Eger, Ungarn, 3300
      • Kaposvár, Ungarn, 7400
      • Szombathely, Ungarn, 8800

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 with genotype 1 chronic hepatitis C (CHC) infection taking triple combination therapy (boceprevir, peginterferon alfa-2a and ribavirin)

Beskrivelse

Inclusion Criteria:

  • 18 years of age or over
  • Genotype 1 CHC infection
  • Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants)
  • Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling
  • Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase)

Exclusion Criteria:

  • Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop < 1 log10) or at week 12 (HCV RNA >/= 15 international units/milliliter [IU/mL]) and switching to triple combination therapy with boceprevir

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
Triple Combination Therapy
Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Medicin: Boceprevir
Boceprevir administered according to corresponding summary of product characteristics (SmPC).
Andre navne:
  • Victrelis
Medicin: Simeprevir
Simeprevir administered according to corresponding summary of product characteristics (SmPC).
Andre navne:
  • Olysio
Medicin: Pegylated Interferon (Peginterferon) Alfa-2a
Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).
Andre navne:
  • Pegasys
Medicin: Ribavirin
Ribavirin according to corresponding summary of product characteristics (SmPC).
Andre navne:
  • Copegus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sustained Virological Response 24 (SVR24) Rate
Tidsramme: 24 weeks after end of treatment (EOT) at Week 72
The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.
24 weeks after end of treatment (EOT) at Week 72

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Virological Response
Tidsramme: Weeks 4, 8, 12, and 24
Virological response is defined as HCV RNA <15 IU/mL.
Weeks 4, 8, 12, and 24
Number of Participants With Virological Breakthrough
Tidsramme: Up to Week 48
Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.
Up to Week 48
Number of Participants With Virological Relapse
Tidsramme: Week 49 up to Week 72
Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.
Week 49 up to Week 72
Number of Participants With Treatment Discontinuation Due to Futility
Tidsramme: Up to Week 48
Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.
Up to Week 48
Number of Participants With Treatment Discontinuation
Tidsramme: Up to Week 48
Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.
Up to Week 48
Number of Participants With Adverse Events
Tidsramme: Up to 72 weeks
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Up to 72 weeks
Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate
Tidsramme: Screening (before Week 1)
Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.
Screening (before Week 1)
Percentage of Participants With Positive Predictive Value of Liver Fibrosis
Tidsramme: Screening (before Week 1)
The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.
Screening (before Week 1)
Predictive Value of HCV Disease Characteristics
Tidsramme: Screening (before Week 1)
HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.
Screening (before Week 1)
Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)
Tidsramme: Up to 72 weeks
Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.
Up to 72 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

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

1. maj 2014

Primær færdiggørelse (Faktiske)

1. maj 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

16. april 2014

Først indsendt, der opfyldte QC-kriterier

16. april 2014

Først opslået (Skøn)

21. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML29278

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