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VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

14. mai 2014 oppdatert av: Janssen Infectious Diseases BVBA

A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Studietype

Intervensjonell

Registrering (Faktiske)

744

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Australia
      • Adelaide, Australia
      • Camperdown, Australia
      • Clayton, Australia
      • Darlinghurst, Australia
      • Fitzroy, Australia
      • Greenslopes, Australia
      • Melbourne, Australia
      • Perth, Australia
  • Belgia
      • Antwerpen, Belgia
      • Brussels, Belgia
      • Genk, Belgia
      • Gent, Belgia
      • Leuven, Belgia
      • Liege, Belgia
  • Brasil
      • Campinas, Brasil
      • Salvador, Brasil
      • Santo Andre, Brasil
      • Sao Paulo, Brasil
      • São Paulo, Brasil
  • Forente stater
    • California
      • La Jolla, California, Forente stater
      • Los Angeles, California, Forente stater
      • San Diego, California, Forente stater
    • Colorado
      • Aurora, Colorado, Forente stater
    • Connecticut
      • New Haven, Connecticut, Forente stater
    • Florida
      • Bradenton, Florida, Forente stater
      • Jacksonville, Florida, Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater
      • Marietta, Georgia, Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater
      • Downers Grove, Illinois, Forente stater
    • Louisiana
      • New Orleans, Louisiana, Forente stater
    • Maryland
      • Lutherville, Maryland, Forente stater
    • Missouri
      • Kansas City, Missouri, Forente stater
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater
    • New Jersey
      • Egg Harbor Twp, New Jersey, Forente stater
    • New Mexico
      • Santa Fe, New Mexico, Forente stater
    • New York
      • New York, New York, Forente stater
    • North Carolina
      • Charlotte, North Carolina, Forente stater
      • Durham, North Carolina, Forente stater
      • Statesville, North Carolina, Forente stater
      • Winston Salem, North Carolina, Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater
      • Hershey, Pennsylvania, Forente stater
      • Philadelphia, Pennsylvania, Forente stater
      • Pittsburgh, Pennsylvania, Forente stater
    • Rhode Island
      • Providence, Rhode Island, Forente stater
    • South Carolina
      • Charleston, South Carolina, Forente stater
      • Columbia, South Carolina, Forente stater
    • Texas
      • Arlington, Texas, Forente stater
      • Dallas, Texas, Forente stater
      • Houston, Texas, Forente stater
      • San Antonio, Texas, Forente stater
    • Virginia
      • Falls Church, Virginia, Forente stater
      • Norfolk, Virginia, Forente stater
    • Washington
      • Seattle, Washington, Forente stater
  • Frankrike
      • Clichy, Frankrike
      • Creteil, Frankrike
      • Grenoble, Frankrike
      • Lille, Frankrike
      • Lyon, Frankrike
      • Paris, Frankrike
      • Pessac, Frankrike
      • Vandoeuvre Les Nancy, Frankrike
      • Villejuif Cedex, Frankrike
  • Irland
      • Dublin, Irland
      • Dublin 9, Irland
  • Mexico
      • Mex Ctity, Mexico
      • Mexico, Mexico
      • Monterrey, Mexico
  • Polen
      • Bialystok, Polen
      • Bydgoszcz, Polen
      • Czeladz, Polen
      • Kielce, Polen
      • Krakow, Polen
      • Warszawa, Polen
  • Spania
      • Barcelona, Spania
      • Barcelona N/A, Spania
      • Madrid, Spania
      • Malaga N/A, Spania
      • Santander N/A, Spania
      • Sevilla N/A, Spania
      • Valencia, Spania
  • Storbritannia
      • Birmingham, Storbritannia
      • Edinburgh, Storbritannia
      • Glasgow, Storbritannia
      • London, Storbritannia
      • Manchester, Storbritannia
  • Sverige
      • Göteborg, Sverige
      • Malmö, Sverige
      • Stockholm, Sverige
  • Tyskland
      • Berlin, Tyskland
      • Bochum, Tyskland
      • Essen, Tyskland
      • Frankfurt, Tyskland
      • Hamburg, Tyskland
      • Kiel, Tyskland
      • Mainz, Tyskland
      • Regensburg, Tyskland
  • Østerrike
      • Graz N/A, Østerrike
      • Linz, Østerrike
      • Wien, Østerrike

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 til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
  • Patients should not have had any previous treatment for hepatitis C
  • Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
  • Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
  • A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

  • Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
  • Patient has a pre-existing psychiatric condition
  • Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
  • Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
  • Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Legemiddel: Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Legemiddel: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Legemiddel: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Legemiddel: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks
Eksperimentell: 002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Legemiddel: Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Legemiddel: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Legemiddel: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Legemiddel: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Tidsramme: End of trial, 12 weeks after last planned dose
The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
End of trial, 12 weeks after last planned dose

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Tidsramme: End of trial, 24 weeks after last planned dose
The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
End of trial, 24 weeks after last planned dose
Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Tidsramme: End of trial, 72 weeks after the start of study medication
The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
End of trial, 72 weeks after the start of study medication
Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Tidsramme: Baseline, Week 4 and Week 4+12.
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
Baseline, Week 4 and Week 4+12.
Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Tidsramme: Week 4, 12, 24, 32, 40
The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
Week 4, 12, 24, 32, 40
Percentage of Participants Who Relapsed During Follow-up Period
Tidsramme: During Follow-Up (24 weeks after the last dose of study drug)
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
During Follow-Up (24 weeks after the last dose of study drug)
Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Tidsramme: End of trial, 12 weeks after the last planned dose
The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
End of trial, 12 weeks after the last planned dose

Samarbeidspartnere og etterforskere

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

Sponsor

Janssen Infectious Diseases BVBA

Samarbeidspartnere

Vertex Pharmaceuticals Incorporated

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. desember 2010

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

28. oktober 2010

Først innsendt som oppfylte QC-kriteriene

12. november 2010

Først lagt ut (Anslag)

16. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. juni 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2014

Sist bekreftet

1. mai 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR013711
  • OPTIMIZE-HCV (Annen identifikator: Janssen Infectious Diseases BVBA)
  • VX-950-C211 (Annen identifikator: Janssen Infectious Diseases BVBA)
  • 2010-021628-84 (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. .

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