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

31 mars 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

64

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Läkemedel: PINNE
Pegylerat interferon alfa-2a (PEG) 180 μg administrerades en gång i veckan genom subkutan injektion.
Andra namn:
  • Pegasys®
Läkemedel: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Andra namn:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Läkemedel: 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).
Andra namn:
  • Copegus®
Experimentell: 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)
Läkemedel: PINNE
Pegylerat interferon alfa-2a (PEG) 180 μg administrerades en gång i veckan genom subkutan injektion.
Andra namn:
  • Pegasys®
Läkemedel: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Andra namn:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Läkemedel: 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).
Andra namn:
  • Copegus®
Experimentell: 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)
Läkemedel: PINNE
Pegylerat interferon alfa-2a (PEG) 180 μg administrerades en gång i veckan genom subkutan injektion.
Andra namn:
  • Pegasys®
Läkemedel: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Andra namn:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Läkemedel: 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).
Andra namn:
  • 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)
Läkemedel: PINNE
Pegylerat interferon alfa-2a (PEG) 180 μg administrerades en gång i veckan genom subkutan injektion.
Andra namn:
  • Pegasys®
Läkemedel: 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).
Andra namn:
  • Copegus®
Läkemedel: Placebo
Placebo to match sofosbuvir administered orally once daily

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Circulating HCV RNA at Week 4
Tidsram: Baseline to Week 4
Baseline to Week 4
Percentage of Participants With Rapid Virologic Response at Week 4
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to Week 4
Baseline to Week 4

Samarbetspartners och utredare

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Sponsor

Gilead Sciences

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 april 2010

Avslutad studie (Faktisk)

1 augusti 2011

Studieregistreringsdatum

Först inskickad

21 januari 2010

Först inskickad som uppfyllde QC-kriterierna

21 januari 2010

Första postat (Uppskatta)

22 januari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 april 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 mars 2014

Senast verifierad

1 mars 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P7977-0221

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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