A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
5 décembre 2013 mis à jour par: Tibotec BVBA
A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment.
Standard treatment is defined as treatment with Peg-INF and RBV.
The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone.
The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period.
Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders).
Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks.
Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks.
Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks.
In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment.
Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks.
Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks.
RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.
Type d'étude
Interventionnel
Inscription (Réel)
663
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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Düsseldorf, Allemagne
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Frankfurt N/A, Allemagne
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Freiburg, Allemagne
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Hamburg, Allemagne
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Hannover, Allemagne
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Koln, Allemagne
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München, 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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Kingswood, Australie
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Melbourne, Australie
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Parkville - Vic, Australie
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Perth, Australie
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Brussels, Belgique
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Bruxelles, Belgique
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Gent, Belgique
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Leuven, Belgique
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Distrito Barao Geraldo-Campina, 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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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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Ottawa, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Barcelona, Espagne
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Madrid, 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 N/A, France
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Grenoble, France
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Lille Cedex, France
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Lyon, France
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Lyon Cedex 02, France
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Marseille, 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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Haifa, Israël
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Jerusalem, Israël
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Petah Tiqva, Israël
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Tel-Aviv, Israël
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Zefat, Israël
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Graz N/A, L'Autriche
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Wien, L'Autriche
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Amsterdam Zuidoost, Pays-Bas
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Leiden, Pays-Bas
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Nijmegen, Pays-Bas
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Bialystok, Pologne
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Czeladz, Pologne
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Kielce, Pologne
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Lodz, Pologne
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Warszawa, Pologne
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Santurce, Porto Rico
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Birmingham, Royaume-Uni
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London, Royaume-Uni
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St Gallen, Suisse
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Zurich N/A, Suisse
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Stockholm, Suède
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Alabama
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Birmingham, Alabama, États-Unis
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California
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Coronado, California, États-Unis
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La Jolla, California, États-Unis
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Los Angeles, California, États-Unis
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San Francisco, California, États-Unis
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Colorado
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Aurora, Colorado, États-Unis
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Florida
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Bradenton, Florida, États-Unis
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Gainesville, Florida, États-Unis
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Miami, Florida, États-Unis
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Georgia
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Atlanta, Georgia, États-Unis
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Indiana
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Indianapolis, Indiana, États-Unis
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Maryland
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Baltimore, Maryland, États-Unis
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Massachusetts
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Boston, Massachusetts, États-Unis
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Worcester, Massachusetts, États-Unis
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Michigan
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Detroit, Michigan, États-Unis
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Minnesota
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Plymouth, Minnesota, États-Unis
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Missouri
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Kansas City, Missouri, 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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Albuquerque, New Mexico, États-Unis
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New York
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Manhasset, New York, États-Unis
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New York, New York, États-Unis
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North Carolina
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Chapel Hill, North Carolina, États-Unis
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Durham, North Carolina, États-Unis
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis
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South Carolina
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Columbia, South Carolina, États-Unis
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Texas
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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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Richmond, Virginia, 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 must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
- Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
- Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria:
- Patient is a previous non-responder that is classified as a viral breakthrough case
- Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
- Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
- Evidence of decompensated liver disease
- Patient has condition that requires use of systemic corticosteroids
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: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Group A: T12/PR48
Participants will receive 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.
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Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
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Expérimental: Group B: T12(DS)/PR48
Participants will receive 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.
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Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
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Expérimental: Group C: Pbo/PR48
Participants will receive placebo in combination with Peg- IFN-alfa-2a and ribavirin for 16 weeks.
Participants will receive Peg- IFN-alfa-2a and ribavirin for next 32 weeks.
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Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned
Délai: Week 72
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SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.
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Week 72
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
Délai: Week 4
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RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
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Week 4
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Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)
Délai: Week 48
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Week 48
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Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned
Délai: Week 60
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SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).
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Week 60
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Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
Délai: Week 4, Week 6, or Week 8
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Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.
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Week 4, Week 6, or Week 8
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Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)
Délai: Up to Week 72
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Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).
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Up to Week 72
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Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4
Délai: Baseline (Day 1) to Week 4
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Baseline (Day 1) to Week 4
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Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12
Délai: Week 4 and Week 12
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Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.
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Week 4 and Week 12
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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
- Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.
- Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.
- Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.
- Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.
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 octobre 2008
Achèvement primaire (Réel)
1 juillet 2010
Achèvement de l'étude (Réel)
1 juillet 2010
Dates d'inscription aux études
Première soumission
19 juin 2008
Première soumission répondant aux critères de contrôle qualité
19 juin 2008
Première publication (Estimation)
23 juin 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
22 janvier 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 décembre 2013
Dernière vérification
1 décembre 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite chronique
- Hépatite
- Hépatite A
- Hépatite C
- Hépatite C chronique
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Antimétabolites
- Agents antinéoplasiques
- Ribavirine
- Peginterféron alfa-2a
- Interféron alpha-2
Autres numéros d'identification d'étude
- CR014842
- VX-950-TIDP24-C216 (Autre identifiant: Tibotec-Virco Virology BVBA)
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 .
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