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Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

7. august 2015 opdateret af: Boehringer Ingelheim

Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)

To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Fase 2

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
        • 1220.40.1004 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1220.40.1001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada
        • 1220.40.1002 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1220.40.1003 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1220.40.1005 Boehringer Ingelheim Investigational Site
  • Forenede Stater
    • Mississippi
      • Tulepo, Mississippi, Forenede Stater
        • 1220.40.002 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, Forenede Stater
        • 1220.40.007 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Germantown, Tennessee, Forenede Stater
        • 1220.40.006 Boehringer Ingelheim Investigational Site
      • Jackson, Tennessee, Forenede Stater
        • 1220.40.004 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, Forenede Stater
        • 1220.40.003 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater
        • 1220.40.005 Boehringer Ingelheim Investigational Site
  • Frankrig
      • Clichy, Frankrig
        • 1220.40.3303A Boehringer Ingelheim Investigational Site
      • Lille, Frankrig
        • 1220.40.3305A Boehringer Ingelheim Investigational Site
      • Marseille, Frankrig
        • 1220.40.3301A Boehringer Ingelheim Investigational Site
      • Montpellier, Frankrig
        • 1220.40.3306A Boehringer Ingelheim Investigational Site
      • Paris, Frankrig
        • 1220.40.3302A Boehringer Ingelheim Investigational Site
      • Rennes Cedex 09, Frankrig
        • 1220.40.3304A Boehringer Ingelheim Investigational Site
  • Rumænien
      • Bucharest, Rumænien
        • 1220.40.4001 Boehringer Ingelheim Investigational Site
      • Bucharest, Rumænien
        • 1220.40.4002 Boehringer Ingelheim Investigational Site
      • Bucharest, Rumænien
        • 1220.40.4003 Boehringer Ingelheim Investigational Site
  • Tyskland
      • Berlin, Tyskland
        • 1220.40.4902 Boehringer Ingelheim Investigational Site
      • Berlin, Tyskland
        • 1220.40.4909 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Tyskland
        • 1220.40.4906 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Tyskland
        • 1220.40.4908 Boehringer Ingelheim Investigational Site
      • Hamburg, Tyskland
        • 1220.40.4904 Boehringer Ingelheim Investigational Site
      • Mainz, Tyskland
        • 1220.40.4905 Boehringer Ingelheim Investigational Site
  • Østrig
      • Linz, Østrig
        • 1220.40.4303 Boehringer Ingelheim Investigational Site
      • Wien, Østrig
        • 1220.40.4301 Boehringer Ingelheim Investigational Site

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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  1. Chronic hepatitis C infection of genotype 1
  2. Therapy-naïve to interferon, pegylated interferon, and ribavirin
  3. HCV viral load > 100.000 IU/ml at screening
  4. Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
  5. Normal retinal finding on fundoscopy within 6 months prior to Day 1
  6. Age 18 to 70 years

Exclusion criteria:

  1. HCV of mixed genotype (1/2, 1/3, and 1/4) .
  2. Patients who have been previously treated with at least one dose of any protease inhibitor
  3. Evidence of liver disease due to causes other than chronic HCV infection
  4. Positive for HIV-1 or HIV-2 antibodies
  5. Hepatitis B virus (HBV) infection
  6. Decompensated liver disease, or history of decompensated liver disease
  7. Active malignancy or history of malignancy within the last 5 years
  8. History of alcohol or drug abuse (except cannabis) within the past 12 months.
  9. Body Mass Index < 18 or > 35 kg/m2.
  10. Usage of any investigational drugs within 30 days prior to enrolment
  11. Alpha fetoprotein value >100ng/mL at screening;
  12. Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.
  13. ALT or AST level > 10 x ULN

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: short arm
patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
Medicin: BI 201335
BI 201335
Medicin: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
Medicin: Ribavirin (RBV)
Ribavirin (RBV)
Eksperimentel: long arm
patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
Medicin: BI 201335
BI 201335
Medicin: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
Medicin: Ribavirin (RBV)
Ribavirin (RBV)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Virological Response at Week 28 (W28VR)
Tidsramme: 28 weeks
Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
28 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rapid Virological Response at Week 4 (RVR)
Tidsramme: 4 weeks
Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.
4 weeks
Virological Response at Week 24 (W24VR)
Tidsramme: 24 weeks
virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.
24 weeks
Virological Response at Week 36 (W36VR)
Tidsramme: 36 weeks
Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.
36 weeks
End of Treatment Response (ETR)
Tidsramme: up to 48 weeks
End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.
up to 48 weeks
Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy
Tidsramme: 72 weeks
Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.
72 weeks
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up
Tidsramme: From baseline to 72 weeks
Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.
From baseline to 72 weeks
Time to Reach a Plasma HCV RNA Level BLD While on Treatment
Tidsramme: 48 weeks
Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment
48 weeks
Laboratory Test Abnormalities and Study Medication Tolerabilities
Tidsramme: 48 weeks
Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.
48 weeks
Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination
Tidsramme: 48 weeks
No number of participants with clinically relevant abnormalities in vital signs and physical examination.
48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)
Tidsramme: baseline and 48 weeks
Change from baseline (CFB) in Red blood cells.
baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
Tidsramme: baseline and 48 weeks
Change from baseline (CFB) in haematocrit and Eosinophils.
baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
Tidsramme: baseline and 48 weeks
Change from baseline (CFB) in Platelets and white blood cells.
baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
Tidsramme: baseline and 48 weeks
Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
Tidsramme: baseline and 48 weeks
Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.
baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)
Tidsramme: baseline and 48 weeks
Change from baseline (CFB) in PT-INR (ratio).
baseline and 48 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Boehringer Ingelheim

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

Hjælpsomme links

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. september 2009

Primær færdiggørelse (Faktiske)

1. april 2011

Datoer for studieregistrering

Først indsendt

24. september 2009

Først indsendt, der opfyldte QC-kriterier

24. september 2009

Først opslået (Skøn)

25. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1220.40
  • 2009-012579-90 (EudraCT nummer: EudraCT)

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 .

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