- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00882908
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment (PILLAR)
19 mei 2014 bijgewerkt door: Tibotec Pharmaceuticals, Ireland
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects
The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a randomized (study medication assigned by chance), 5-arm, double-blind (neither investigator nor the participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study) study to compare the efficacy, tolerability and safety of different TMC435 regimens combined with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) versus PegIFNα-2a plus RBV alone in adult treatment-naive patients with chronic genotype 1 HCV infection.
The study mainly consists of 3 phases: screening phase (approximately 6 weeks), treatment phase (up to 48 weeks), and follow up phase (up to 48 weeks).
In the treatment phase, patients will be divided in to 5 different arms in a 1:1:1:1:1 randomized ratio.
In treatment arms 1 and 2, patients will receive 12 weeks of therapy with TMC435 along with PegIFNα 2a and RBV followed by treatment with PegIFNα 2a, RBV, and TMC435-matched placebo.
In treatment arms 3 and 4, patients will receive 24 weeks of therapy with TMC435, PegIFNα 2a, and RBV.
In treatment arm 5 (control group), patients will receive PegIFNα 2a and RBV for 48 weeks and TMC435 matched placebo for the first 24 weeks.
Collection of blood samples for efficacy evaluations will be done at scheduled visits throughout the study.
Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study.
The total duration of the study will be up to approximately 72 weeks after initiation of treatment.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
386
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Concord, Australië
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Darlinghurst, Australië
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Fitzroy, Australië
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Melbourne, Australië
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Sydney, Australië
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Woolloongabba N/A, Australië
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Brugge, België
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Brussels, België
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Bruxelles, België
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Edegem, België
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Gent, België
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Leuven, België
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Roeselare, België
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Alberta
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Calgary, Alberta, Canada
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Ontario
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Aarhus, Denemarken
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Copenhagen, Denemarken
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Hvidovre N/A, Denemarken
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Kolding, Denemarken
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Odense N/A, Denemarken
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Berlin, Duitsland
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Düsseldorf, Duitsland
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Frankfurt A. M., Duitsland
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Freiburg, Duitsland
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Hamburg, Duitsland
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Hannover, Duitsland
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Köln, Duitsland
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Stuttgart, Duitsland
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Würzburg, Duitsland
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Clichy, Frankrijk
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Creteil N/A, Frankrijk
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Grenoble, Frankrijk
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Lyon, Frankrijk
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Nice, Frankrijk
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Paris, Frankrijk
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Vandoeuvre Les Nancy, Frankrijk
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Auckland, Nieuw-Zeeland
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Christchurch, Nieuw-Zeeland
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Hamilton, Nieuw-Zeeland
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Bergen, Noorwegen
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Nordbyhagen, Noorwegen
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Oslo, Noorwegen
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Tromsø, Noorwegen
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Wien, Oostenrijk
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Bialystok, Polen
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Bydgoszcz, Polen
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Czeladz, Polen
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Kielce, Polen
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Lodz, Polen
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Warschau, Polen
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Moscow, Russische Federatie
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Nizhny Novgorod, Russische Federatie
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Saint-Petersburg, Russische Federatie
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Samara, Russische Federatie
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Smolensk, Russische Federatie
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St Petersburg, Russische Federatie
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Barcelona, Spanje
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Madrid, Spanje
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Sevilla N/A, Spanje
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Valencia, Spanje
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California
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Los Angeles, California, Verenigde Staten
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Florida
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Jacksonville, Florida, Verenigde Staten
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Orlando, Florida, Verenigde Staten
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Palm Harbor, Florida, Verenigde Staten
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Illinois
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Chicago, Illinois, Verenigde Staten
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Louisiana
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New Orleans, Louisiana, Verenigde Staten
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Minnesota
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Saint Paul, Minnesota, Verenigde Staten
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New York
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New York, New York, Verenigde Staten
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten
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Ohio
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Cincinnati, Ohio, Verenigde Staten
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Tennessee
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Germantown, Tennessee, Verenigde Staten
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Virginia
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Charlottesville, Virginia, Verenigde Staten
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Patients with documented chronic genotype-1 hepatitis C infection and with plasma HCV RNA of > 100,000 IU/mL at screening
- Patients that have not been treated before for HCV
- Patients that are of childbearing potential or have a partner of childbearing potential should agree to use 2 effective methods of contraception
Exclusion Criteria:
- Patients with cirrhosis or evidence of hepatic decompensation
- Co-infection with the human immunodeficiency virus (HIV)
- Any contraindication to Pegasys or Copegus therapy
- History of, or any current medical condition which could impact the safety of the patient in the study
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: TMC435 75 mg 12 Wks + PR 24/48
Participants will receive TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks.
Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria.
All other participants continued PR until Week 48.
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TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.
Andere namen:
Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.
Andere namen:
PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.
Andere namen:
Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
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Experimenteel: TMC435 75 mg 24 Wks + PR 24/48
Participants will receive TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks.
Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria.
All other participants continued PR until Week 48.
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TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.
Andere namen:
Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.
Andere namen:
PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.
Andere namen:
Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
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Experimenteel: TMC435 150 mg 12 Wks + PR 24/48
Participants will receive TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks.
Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria.
All other participants continued PR until Week 48.
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TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.
Andere namen:
Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.
Andere namen:
PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.
Andere namen:
Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
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Experimenteel: TMC435 150 mg 24 Wks + PR 24/48
Participants will receive TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks.
Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria.
All other participants continued PR until Week 48.
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TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.
Andere namen:
Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.
Andere namen:
PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.
Andere namen:
Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
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Placebo-vergelijker: Placebo 24 Wks + PR48
Participants will receive Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
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Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.
Andere namen:
PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.
Andere namen:
Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Het percentage deelnemers dat een aanhoudende virologische respons bereikt in week 72 (SVRW72)
Tijdsspanne: Week 72
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De onderstaande tabel toont het percentage deelnemers in elke behandelingsgroep dat een SVRW72 bereikte, gedefinieerd als het percentage deelnemers met niet-detecteerbare plasmawaarden van hepatitis C-virusribonucleïnezuur aan het einde van de behandeling (EOT) en in week 72.
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Week 72
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Het percentage deelnemers dat een snelle virologische respons (RVR) bereikt
Tijdsspanne: Week 4
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De onderstaande tabel toont het percentage deelnemers in elke behandelingsgroep die een RVR bereikten, gedefinieerd als niet-detecteerbare plasmawaarden van hepatitis C-virusribonucleïnezuur na 4 weken behandeling.
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Week 4
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Het percentage deelnemers dat een volledige vroege virologische respons (cEVR) bereikt
Tijdsspanne: Week 12
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De onderstaande tabel toont het percentage deelnemers in elke behandelingsgroep die een cEVR hadden, gedefinieerd als niet-detecteerbare plasmawaarden van hepatitis C-virusribonucleïnezuur in week 12.
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Week 12
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The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up
Tijdsspanne: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
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The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
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Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
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The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Tijdsspanne: Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
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The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
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Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
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The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment
Tijdsspanne: Baseline (Day 1) and Weeks, 2, 4, 8, and 12
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The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.
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Baseline (Day 1) and Weeks, 2, 4, 8, and 12
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The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
Tijdsspanne: Week 48 or 72
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The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.
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Week 48 or 72
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The Percentage of Participants Achieving an Early Virologic Response (EVR)
Tijdsspanne: Baseline (Day 1) and Week 12
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The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.
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Baseline (Day 1) and Week 12
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The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
Tijdsspanne: Up to Week 36 or 52
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The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.
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Up to Week 36 or 52
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Number of Participants With Viral Breakthrough
Tijdsspanne: Week 24 or 48
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The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).
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Week 24 or 48
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The Number of Participants With Viral Relapse
Tijdsspanne: Up to Week 72
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The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.
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Up to Week 72
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The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)
Tijdsspanne: Baseline (Day 1) up to Week 24 or 48
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The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.
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Baseline (Day 1) up to Week 24 or 48
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Plasma Concentrations of TMC435
Tijdsspanne: Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
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The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.
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Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
Tijdsspanne: Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
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The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups.
Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).
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Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.
- Scott J, Rosa K, Fu M, Cerri K, Peeters M, Beumont M, Zeuzem S, Evon DM, Gilles L. Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection. BMC Infect Dis. 2014 Aug 26;14:465. doi: 10.1186/1471-2334-14-465.
- Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013 Dec;58(6):1918-29. doi: 10.1002/hep.26641. Epub 2013 Oct 11.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2009
Primaire voltooiing (Werkelijk)
1 april 2010
Studie voltooiing (Werkelijk)
1 april 2011
Studieregistratiedata
Eerst ingediend
16 april 2009
Eerst ingediend dat voldeed aan de QC-criteria
16 april 2009
Eerst geplaatst (Schatting)
17 april 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
16 juni 2014
Laatste update ingediend die voldeed aan QC-criteria
19 mei 2014
Laatst geverifieerd
1 mei 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Enterovirusinfecties
- Picornaviridae-infecties
- Hepatitis
- Hepatitis A
- Hepatitis C
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten
- Proteaseremmers
- Ribavirine
- Simeprevir
Andere studie-ID-nummers
- CR015799
- TMC435-TiDP16-C205 (Andere identificatie: Tibotec Pharmaceuticals, Ireland)
- 2008-007147-13 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Tripep ABInovio PharmaceuticalsOnbekendChronische hepatitis C-virusinfectieZweden
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Tibotec Pharmaceuticals, IrelandVoltooid
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Janssen R&D IrelandVoltooid
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Tibotec Pharmaceuticals, IrelandVoltooid
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Tibotec Pharmaceuticals, IrelandVoltooid
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