VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
14 mai 2014 mis à jour par: Janssen Infectious Diseases BVBA
A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.
Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.
Type d'étude
Interventionnel
Inscription (Réel)
744
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne
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Bochum, Allemagne
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Essen, Allemagne
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Frankfurt, Allemagne
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Hamburg, Allemagne
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Kiel, Allemagne
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Mainz, Allemagne
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Regensburg, Allemagne
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Adelaide, Australie
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Camperdown, Australie
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Clayton, Australie
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Darlinghurst, Australie
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Fitzroy, Australie
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Greenslopes, Australie
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Melbourne, Australie
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Perth, Australie
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Antwerpen, Belgique
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Brussels, Belgique
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Genk, Belgique
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Gent, Belgique
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Leuven, Belgique
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Liege, Belgique
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Campinas, Brésil
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Salvador, Brésil
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Santo Andre, Brésil
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Sao Paulo, Brésil
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São Paulo, Brésil
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Barcelona, Espagne
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Barcelona N/A, Espagne
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Madrid, Espagne
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Malaga N/A, Espagne
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Santander N/A, Espagne
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Sevilla N/A, Espagne
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Valencia, Espagne
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Clichy, France
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Creteil, France
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Grenoble, France
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Lille, France
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Lyon, France
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Paris, France
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Pessac, France
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Vandoeuvre Les Nancy, France
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Villejuif Cedex, France
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Dublin, Irlande
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Dublin 9, Irlande
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Graz N/A, L'Autriche
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Linz, L'Autriche
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Wien, L'Autriche
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Mex Ctity, Mexique
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Mexico, Mexique
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Monterrey, Mexique
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Bialystok, Pologne
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Bydgoszcz, Pologne
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Czeladz, Pologne
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Kielce, Pologne
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Krakow, Pologne
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Warszawa, Pologne
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Birmingham, Royaume-Uni
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Edinburgh, Royaume-Uni
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Glasgow, Royaume-Uni
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London, Royaume-Uni
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Manchester, Royaume-Uni
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Göteborg, Suède
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Malmö, Suède
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Stockholm, Suède
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California
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La Jolla, California, États-Unis
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Los Angeles, California, États-Unis
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San Diego, California, États-Unis
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Colorado
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Aurora, Colorado, États-Unis
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Connecticut
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New Haven, Connecticut, États-Unis
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Florida
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Bradenton, Florida, États-Unis
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Jacksonville, Florida, États-Unis
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Georgia
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Atlanta, Georgia, États-Unis
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Marietta, Georgia, États-Unis
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Illinois
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Chicago, Illinois, États-Unis
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Downers Grove, Illinois, États-Unis
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Louisiana
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New Orleans, Louisiana, États-Unis
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Maryland
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Lutherville, Maryland, États-Unis
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Missouri
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Kansas City, Missouri, États-Unis
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New Hampshire
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Lebanon, New Hampshire, États-Unis
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New Jersey
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Egg Harbor Twp, New Jersey, États-Unis
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New Mexico
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Santa Fe, New Mexico, États-Unis
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New York
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New York, New York, États-Unis
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North Carolina
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Charlotte, North Carolina, États-Unis
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Durham, North Carolina, États-Unis
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Statesville, North Carolina, États-Unis
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Winston Salem, North Carolina, États-Unis
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Ohio
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Cincinnati, Ohio, États-Unis
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Pennsylvania
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Allentown, Pennsylvania, États-Unis
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Hershey, Pennsylvania, États-Unis
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Philadelphia, Pennsylvania, États-Unis
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Pittsburgh, Pennsylvania, États-Unis
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Rhode Island
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Providence, Rhode Island, États-Unis
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South Carolina
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Charleston, South Carolina, États-Unis
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Columbia, South Carolina, États-Unis
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Texas
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Arlington, Texas, États-Unis
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Dallas, Texas, États-Unis
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Houston, Texas, États-Unis
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San Antonio, Texas, États-Unis
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Virginia
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Falls Church, Virginia, États-Unis
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Norfolk, Virginia, États-Unis
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Washington
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Seattle, Washington, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
- Patients should not have had any previous treatment for hepatitis C
- Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
- Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.
Exclusion Criteria:
- Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
- Patient has a pre-existing psychiatric condition
- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
- Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
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Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 weeks
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Expérimental: 002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
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Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 weeks
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Délai: End of trial, 12 weeks after last planned dose
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The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned).
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
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End of trial, 12 weeks after last planned dose
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Délai: End of trial, 24 weeks after last planned dose
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The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication.
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time.
Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
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End of trial, 24 weeks after last planned dose
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Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Délai: End of trial, 72 weeks after the start of study medication
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The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned).
SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
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End of trial, 72 weeks after the start of study medication
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Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Délai: Baseline, Week 4 and Week 4+12.
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The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
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Baseline, Week 4 and Week 4+12.
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Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Délai: Week 4, 12, 24, 32, 40
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The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
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Week 4, 12, 24, 32, 40
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Percentage of Participants Who Relapsed During Follow-up Period
Délai: During Follow-Up (24 weeks after the last dose of study drug)
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The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
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During Follow-Up (24 weeks after the last dose of study drug)
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Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Délai: End of trial, 12 weeks after the last planned dose
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The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
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End of trial, 12 weeks after the last planned dose
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.
- Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2010
Achèvement primaire (Réel)
1 août 2012
Achèvement de l'étude (Réel)
1 novembre 2012
Dates d'inscription aux études
Première soumission
28 octobre 2010
Première soumission répondant aux critères de contrôle qualité
12 novembre 2010
Première publication (Estimation)
16 novembre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 juin 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 mai 2014
Dernière vérification
1 mai 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite
- Hépatite A
- Hépatite C
- Maladies virales
- Hépatite chronique
- Hépatite C chronique
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Antimétabolites
- Agents antinéoplasiques
- Facteurs immunologiques
- Interférons
- Interféron-alpha
- Ribavirine
- Peginterféron alfa-2a
- Interféron alpha-2
Autres numéros d'identification d'étude
- CR013711
- OPTIMIZE-HCV (Autre identifiant: Janssen Infectious Diseases BVBA)
- VX-950-C211 (Autre identifiant: Janssen Infectious Diseases BVBA)
- 2010-021628-84 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .