- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01054729
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Santurce, Puerto Rico, 00909
- Fundacion de Investigacion de Diego
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California
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San Francisco, California, Vereinigte Staaten, 94115
- Quest Clinical Research
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Florida
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Gainesville, Florida, Vereinigte Staaten, 32610
- University of Florida
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Orlando, Florida, Vereinigte Staaten, 32803
- Orlando Immunology Center
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University
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Texas
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San Antonio, Texas, Vereinigte Staaten, 78215
- Alamo Medical Research Center
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Washington
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Seattle, Washington, Vereinigte Staaten, 98101
- Virginia Mason Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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)
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Pegyliertes Interferon alfa-2a (PEG) 180 μg wurde einmal wöchentlich durch subkutane Injektion verabreicht.
Andere Namen:
Sofosbuvir tablet(s) administered orally once daily
Andere Namen:
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).
Andere Namen:
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Experimental: 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)
|
Pegyliertes Interferon alfa-2a (PEG) 180 μg wurde einmal wöchentlich durch subkutane Injektion verabreicht.
Andere Namen:
Sofosbuvir tablet(s) administered orally once daily
Andere Namen:
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).
Andere Namen:
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Experimental: 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)
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Pegyliertes Interferon alfa-2a (PEG) 180 μg wurde einmal wöchentlich durch subkutane Injektion verabreicht.
Andere Namen:
Sofosbuvir tablet(s) administered orally once daily
Andere Namen:
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).
Andere Namen:
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Aktiver 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)
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Pegyliertes Interferon alfa-2a (PEG) 180 μg wurde einmal wöchentlich durch subkutane Injektion verabreicht.
Andere Namen:
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).
Andere Namen:
Placebo to match sofosbuvir administered orally once daily
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Zeitfenster: Baseline to Week 4
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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.
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Baseline to Week 4
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Circulating HCV RNA at Week 4
Zeitfenster: Baseline to Week 4
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Baseline to Week 4
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Percentage of Participants With Rapid Virologic Response at Week 4
Zeitfenster: Week 4
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Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.
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Week 4
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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
Zeitfenster: Post-treatment Weeks 12 and 24
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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).
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Post-treatment Weeks 12 and 24
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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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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
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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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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
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Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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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)
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Plasma Pharmacokinetics of GS-331007: Cmax at Day 0
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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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.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-331007: Cmax at Day 27
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of GS-566500: Cmax at Day 0
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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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.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-566500: Cmax at Day 27
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27
Zeitfenster: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Percentage of Participants Who Developed Resistance to Sofosbuvir
Zeitfenster: Baseline to Week 4
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Baseline to Week 4
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P7977-0221
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