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An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants (QUEST-2)

10 juni 2014 uppdaterad av: Janssen R&D Ireland

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a randomized, double-blind (neither physician or participant knows the name of the assigned drug), placebo-controlled study of TMC435 in participants who are infected with genotype 1 hepatitis C virus who have never received treatment for this before. Participants in this study will also receive two other drugs for their infection (either peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®). The purpose of the study is to investigate if TMC435 is superior to placebo in reducing hepatitis C virus to an undetectable level 24 weeks after the end of treatment. For the first 12 weeks, participants will take TMC435 or placebo, plus peginterferon and ribavirin. For the next 12 weeks, participants will take peginterferon and ribavirin only. After that, some participants will continue to take peginterferon and ribavirin for up to 24 additional weeks. Other participants will stop taking peginterferon and ribavirin. The study doctor will inform each participant about how to take their study medication and when they should stop taking it. After a participant stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. The total duration of the study is 78 weeks (including screening). Participants will be monitored for safety throughout the study. Study assessments at each study visit may include but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), participant questionnaires, and physical examinations. TMC435 will be taken as an oral capsule of 150 mg once per day. Peginterferon (Pegasys ®) will be given as an injection of 180 µg once each week. Peginterferon (PegIntron®) will be given as an injection once each week and the dose will depend on your body weight. Ribavirin will be taken as a tablet (Copegus ®) or a capsule (Rebetol ®) twice each day and the dose will depend on your body weight.

Studietyp

Interventionell

Inskrivning (Faktisk)

393

Fas

  • Fas 3

Kontakter och platser

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

Studieorter

  • Argentina
      • Buenos Aires, Argentina
      • Rosario, Santa Fe, Argentina
  • Belgien
      • Antwerpen, Belgien
      • Brugge, Belgien
      • Brussel, Belgien
      • Brussels, Belgien
      • Gent, Belgien
      • Leuven, Belgien
  • Brasilien
      • Salvador, Brasilien
      • Sao Paulo, Brasilien
      • São Paulo, Brasilien
  • Bulgarien
      • Plovdiv, Bulgarien
      • Sofia, Bulgarien
  • Frankrike
      • Clichy, Frankrike
      • Creteil N/A, Frankrike
      • Nice N/A, Frankrike
      • Paris, Frankrike
      • Vandoeuvre Les Nancy, Frankrike
  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna
    • Florida
      • Jacksonville, Florida, Förenta staterna
      • Orlando, Florida, Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna
    • Kentucky
      • Crestview Hills, Kentucky, Förenta staterna
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna
    • Minnesota
      • Saint Paul, Minnesota, Förenta staterna
    • Tennessee
      • Germantown, Tennessee, Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna
      • San Antonio, Texas, Förenta staterna
    • Virginia
      • Falls Church, Virginia, Förenta staterna
  • Kalkon
      • Ankara, Kalkon
      • Istanbul, Kalkon
      • Izmir, Kalkon
  • Nederländerna
      • Amsterdam Zuidoost, Nederländerna
      • Leiden, Nederländerna
  • Polen
      • Bialystok, Polen
      • Bydgoszcz, Polen
      • Chorzow, Polen
      • Czeladz, Polen
      • Kielce, Polen
      • Krakow, Polen
      • Warszawa, Polen
  • Portugal
      • Coimbra, Portugal
      • Lisboa, Portugal
      • Porto, Portugal
  • Puerto Rico
      • Santurce, Puerto Rico
  • Slovakien
      • Bratislava, Slovakien
      • Martin, Slovakien
  • Spanien
      • Barcelona, Spanien
      • Madrid, Spanien
      • Sevilla N/A, Spanien
      • Valencia, Spanien
  • Tyskland
      • Berlin, Tyskland
      • Düsseldorf, Tyskland
      • Freiburg, Tyskland
      • Halle (Saale), Tyskland
      • Hannover, Tyskland
      • Kiel, Tyskland
      • Leipzig, Tyskland
      • Munchen, Tyskland
      • Münster, Tyskland
      • Ulm, Tyskland
  • Österrike
      • Wien, Österrike

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 och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Genotype 1 hepatitis C infection (confirmed at screening)
  • Participant has not received any prior treatment for hepatitis C
  • Participant must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
  • Must agree to use 2 forms of effective contraception throughout study (both males and females)

Exclusion Criteria:

  • Infection with HIV or non genotype 1 hepatitis C
  • Liver disease not related to hepatitic C infection
  • Hepatic decompensation
  • Significant laboratory abnormalities or other active diseases
  • Pregnant or planning to become pregnant

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: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: TMC435
TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 24 or 48 weeks
Läkemedel: TMC435
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
Läkemedel: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)
One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
Andra namn:
  • PegIFNα-2a (Pegasys)
  • PegIFNα-2b (PegIntron)
Läkemedel: Ribavirin (RBV)
200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Andra namn:
  • Copegus
  • Rebetol
Placebo-jämförare: Placebo
Placebo 150 mg capsule once daily for 12 weeks in addition peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 48 weeks
Läkemedel: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)
One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
Andra namn:
  • PegIFNα-2a (Pegasys)
  • PegIFNα-2b (PegIntron)
Läkemedel: Ribavirin (RBV)
200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Andra namn:
  • Copegus
  • Rebetol
Läkemedel: Placebo
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Procentandelen deltagare som uppnår ett ihållande virologiskt svar 12 veckor efter det planerade slutet av behandlingen (SVR12)
Tidsram: Vecka 36 eller Vecka 60
Tabellen nedan visar andelen deltagare i varje behandlingsgrupp som uppnådde en SVR12, definierad som andelen deltagare med odetekterbar plasma Hepatit C-virus ribonukleinsyra 12 veckor efter planerat avslutat behandling.
Vecka 36 eller Vecka 60

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Procentandelen deltagare som uppnår ett ihållande virologiskt svar vid vecka 72 (SVRW72)
Tidsram: Vecka 72
Tabellen nedan visar andelen deltagare i varje behandlingsgrupp som uppnådde en SVRW72, definierad som andelen deltagare med odetekterbara plasmanivåer av hepatit C-virus ribonukleinsyra vid slutet av behandlingen (EOT) och vid vecka 72.
Vecka 72
Andelen deltagare som uppnådde ett ihållande virologiskt svar 24 veckor efter det planerade slutet av behandlingen (SVR24)
Tidsram: Vecka 48 eller Vecka 72
Tabellen nedan visar andelen deltagare i varje behandlingsgrupp som uppnådde ett SVR24, definierat som andelen deltagare med odetekterbara plasmanivåer av hepatit C-virus ribonukleinsyra 24 veckor efter planerat avslutat behandling.
Vecka 48 eller Vecka 72
Andelen deltagare som uppnådde ett ihållande virologiskt svar 4 veckor efter det planerade slutet av behandlingen (SVR4)
Tidsram: Vecka 28 eller Vecka 52
Tabellen nedan visar andelen deltagare i varje behandlingsgrupp som uppnådde en SVR4, definierad som andelen deltagare med odetekterbara plasmanivåer av hepatit C-virus ribonukleinsyra 4 veckor efter planerat avslutat behandling.
Vecka 28 eller Vecka 52
Procentandelen deltagare som uppnår ett snabbt virologiskt svar (RVR)
Tidsram: Vecka 4
Tabellen nedan visar andelen deltagare i varje behandlingsgrupp som uppnådde en RVR, definierad som att ha odetekterbara plasmanivåer av hepatit C-virus ribonukleinsyra efter att ha fått 4 veckors behandling.
Vecka 4
Procentandelen deltagare som uppnår ett fullständigt tidigt virologiskt svar (cEVR)
Tidsram: Vecka 12
Tabellen nedan visar procentandelen deltagare i varje behandlingsgrupp som hade en cEVR, definierad som att ha odetekterbara plasmanivåer av hepatit C-virus ribonukleinsyra vid vecka 12.
Vecka 12
Procentandelen deltagare med <1 log10 minskning av hepatit C-virus (HCV) ribonukleinsyra (RNA) från baslinjen vid vecka 4
Tidsram: Vecka 4
Tabellen nedan visar andelen deltagare i varje behandlingsgrupp med <1 log10 HCV-RNA-minskning vid vecka 4.
Vecka 4
Andel deltagare med hepatit C-virus (HCV) ribonukleinsyranivåer (RNA) >1000 IE/ml vid vecka 4
Tidsram: Vecka 4
Tabellen nedan visar andelen deltagare i varje behandlingsgrupp med HCV RNA-nivåer >1000 IE/ml vid vecka 4.
Vecka 4
Andelen deltagare med viralt genombrott vid olika tidpunkter
Tidsram: Fram till vecka 48
Tabellen nedan visar andelen deltagare vid olika tidpunkter med virusgenombrott, definierat som en bekräftad ökning med mer än 1 log10 IE/ml i plasma HCV-ribonukleinsyranivån (RNA) från den lägsta nivå som uppnåtts (dvs. lägsta värde uppmätt i mellan baslinje och aktuellt värde), eller en bekräftad plasma-HCV-RNA-nivå på mer än 100 IE/ml hos deltagare vars plasma-HCV-RNA tidigare hade legat under kvantifieringsgränsen (25 IE/mL detekterbar) eller ej detekterbar (<25 IE/mL Oupptäckbar).
Fram till vecka 48
Tid från avslutad behandling till viralt återfall
Tidsram: Fram till vecka 72
Tabellen nedan visar medelantalet dagar till viralt återfall, definierat som deltagare som har bekräftat detekterbar plasmanivå av hepatit C-virus (HCV) ribonukleinsyra (RNA) under uppföljningsperioden hos deltagare med odetekterbart plasma-HCV-RNA (<25 IE) /ml ej detekterbar) i slutet av behandlingen.
Fram till vecka 72
Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Tidsram: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
The table below shows changes from baseline in log10 HCV RNA.
Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
Faktiska värden för log10 Hepatit C-virus (HCV) Ribonukleinsyra (RNA)
Tidsram: Dag 3, vecka 1, vecka 4, vecka 12, vecka 24 och vecka 48
Tabellen nedan visar faktiska värden för log10 HCV RNA-nivåer.
Dag 3, vecka 1, vecka 4, vecka 12, vecka 24 och vecka 48
Percentage of Participants With On-treatment Virologic Response at All Time Points
Tidsram: Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42
The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.
Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42
The Percentage of Participants Achieving a Early Virologic Response (EVR)
Tidsram: Week 12
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.
Week 12
The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)
Tidsram: Weeks 4 and 12
The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.
Weeks 4 and 12
Andel deltagare med nollsvar
Tidsram: Vecka 12
Tabellen nedan visar andelen deltagare med noll-svar, definierat som <2 log10-reduktion i hepatit C-virus-ribonukleinsyra vid vecka 12 jämfört med baslinjen.
Vecka 12
Percentage of Participants With Partial Response
Tidsram: Week 12
The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.
Week 12
Andel deltagare med viralt genombrott
Tidsram: Fram till vecka 48
Tabellen nedan visar andelen deltagare med viralt genombrott, definierat som en bekräftad ökning på mer än 1 log10 IE/ml i plasmanivån av hepatit C-virus (HCV) ribonukleinsyra (RNA) från den lägsta nivå som uppnåtts (dvs. lägsta uppmätta värde mellan baslinje och aktuellt värde), eller en bekräftad plasma-HCV-RNA-nivå över 100 IE/ml hos deltagare vars plasma-HCV-RNA tidigare hade legat under gränsen för kvantifiering (25 IE/mL detekterbar) eller ej detekterbar (<25 IE/ mL ej detekterbar).
Fram till vecka 48
Percentage of Participants With Viral Relapse
Tidsram: Up to Week 72
The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.
Up to Week 72
Andel deltagare som slutförde all studiebehandling vid vecka 24 på grund av behandlingslängdsregeln
Tidsram: Vecka 24
Tabellen nedan visar andelen deltagare i TMC435-behandlingsgruppen som uppfyllde behandlingslängdsregeln (dvs. med hepatit C-virus [HCV] ribonukleinsyra [RNA] nivåer <25 IE/mL detekterbara eller odetekterbara vid vecka 4 och odetekterbar HCV RNA nivåer vid vecka 12) och avslutad behandling med PegIFNa-2a och RBV under 24 veckor. Deltagare i TMC435-behandlingsgruppen som inte uppfyllde RGT-kriterierna och deltagare i placebogruppen behandlades med PegIFNa-2a- och RBV-behandling i 48 veckor.
Vecka 24
Andel deltagare med misslyckande under behandling
Tidsram: Vecka 48
Tabellen nedan visar procentandelen av deltagare med misslyckande under behandlingen definierat som bekräftade detekterbara ribonukleinsyranivåer av hepatit C-virus vid det faktiska slutet av behandlingen.
Vecka 48
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable
Tidsram: Up to Week 48
The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.
Up to Week 48
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable
Tidsram: Up to Week 48
The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable.
Up to Week 48
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL
Tidsram: Up to Week 48
The table below shows the median time in days to reach HCV RNA levels <100 IU/mL.
Up to Week 48
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL
Tidsram: Up to Week 48
The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL.
Up to Week 48
The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)
Tidsram: Up to Week 48
The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.
Up to Week 48
Mediantid till normalisering av nivåer av alaninaminotransferas (ALT).
Tidsram: Fram till vecka 48
Tabellen nedan visar mediantiden i veckor till normalisering av ALAT-nivåer.
Fram till vecka 48
Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
Tidsram: At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12
The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435.
At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12
Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)
Tidsram: Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12
The table below shows the mean (standard deviation) of C0h values of TMC435. NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12).
Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12
Plasma Concentration of TMC435: Systemic Clearance (CL)
Tidsram: At protocol-specified time points at Weeks 2, 4, 8, and 12
The table below shows the mean (standard deviation) of CL values of TMC435. NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below.
At protocol-specified time points at Weeks 2, 4, 8, and 12
Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores
Tidsram: Baseline to Week 60 and Week 72
Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504. The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group. The null hypothesis was that there would be no difference between the treatment arms in the FSS total score. The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.
Baseline to Week 60 and Week 72
Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment
Tidsram: Baseline to Week 60 and Week 72
Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores. The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups.
Baseline to Week 60 and Week 72
Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment
Tidsram: Baseline to Week 60 and Week 72
Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities. The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores. The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups.
Baseline to Week 60 and Week 72
Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment
Tidsram: Baseline to Week 60 and Week 72
Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work). The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism. The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group. The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60. The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score.
Baseline to Week 60 and Week 72

Samarbetspartners och utredare

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Sponsor

Janssen R&D Ireland

Publikationer och användbara länkar

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Allmänna publikationer

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 mars 2011

Primärt slutförande (Faktisk)

1 februari 2013

Avslutad studie (Faktisk)

1 februari 2013

Studieregistreringsdatum

Först inskickad

7 januari 2011

Först inskickad som uppfyllde QC-kriterierna

3 februari 2011

Första postat (Uppskatta)

7 februari 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 juni 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juni 2014

Senast verifierad

1 juni 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CR017380
  • TMC435-TiDP16-C216 (Annan identifierare: Janssen R&D Ireland)
  • 2010-021174-11 (EudraCT-nummer)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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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