Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients

31. marts 2014 opdateret af: Gilead Sciences

A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1

Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94115
        • Quest Clinical Research
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida
      • Orlando, Florida, Forenede Stater, 32803
        • Orlando Immunology Center
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University
    • Texas
      • San Antonio, Texas, Forenede Stater, 78215
        • Alamo Medical Research Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason Medical Center
  • Puerto Rico
      • Santurce, Puerto Rico, 00909
        • Fundacion de Investigacion de Diego

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Treatment-naive males and females, 18-65 years of age
  • Genotype 1 HCV infection
  • Negative pregnancy test for females of childbearing age
  • Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

  • Hepatitis B or HIV infection
  • Pregnant or breast feeding females or male partners of pregnant females
  • Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
  • History or evidence of medical condition associated with chronic liver disease other than HCV

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: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sofosbuvir 100 mg+PEG+RBV
Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Medicin: PEG
Pegyleret interferon alfa-2a (PEG) 180 μg blev administreret en gang om ugen ved subkutan injektion.
Andre navne:
  • Pegasys®
Medicin: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Andre navne:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Medicin: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Andre navne:
  • Copegus®
Eksperimentel: Sofosbuvir 200 mg+PEG+RBV
Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Medicin: PEG
Pegyleret interferon alfa-2a (PEG) 180 μg blev administreret en gang om ugen ved subkutan injektion.
Andre navne:
  • Pegasys®
Medicin: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Andre navne:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Medicin: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Andre navne:
  • Copegus®
Eksperimentel: Sofosbuvir 400 mg+PEG+RBV
Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Medicin: PEG
Pegyleret interferon alfa-2a (PEG) 180 μg blev administreret en gang om ugen ved subkutan injektion.
Andre navne:
  • Pegasys®
Medicin: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Andre navne:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Medicin: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Andre navne:
  • Copegus®
Aktiv komparator: Placebo+PEG+RBV
Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Medicin: PEG
Pegyleret interferon alfa-2a (PEG) 180 μg blev administreret en gang om ugen ved subkutan injektion.
Andre navne:
  • Pegasys®
Medicin: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Andre navne:
  • Copegus®
Medicin: Placebo
Placebo to match sofosbuvir administered orally once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Tidsramme: Baseline to Week 4
Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.
Baseline to Week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Circulating HCV RNA at Week 4
Tidsramme: Baseline to Week 4
Baseline to Week 4
Percentage of Participants With Rapid Virologic Response at Week 4
Tidsramme: Week 4
Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.
Week 4
Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment
Tidsramme: Post-treatment Weeks 12 and 24
SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).
Post-treatment Weeks 12 and 24
Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.

Cmax is defined as the maximum concentration of drug.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).

AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).

AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-331007: Cmax at Day 0
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007: Cmax at Day 27
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-566500: Cmax at Day 0
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-566500: Cmax at Day 27
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27
Tidsramme: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Percentage of Participants Who Developed Resistance to Sofosbuvir
Tidsramme: Baseline to Week 4
Baseline to Week 4

Samarbejdspartnere og efterforskere

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

Sponsor

Gilead Sciences

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. januar 2010

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

21. januar 2010

Først indsendt, der opfyldte QC-kriterier

21. januar 2010

Først opslået (Skøn)

22. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P7977-0221

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 PEG

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Moldova

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner