Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1

10 mars 2017 mis à jour par: Hoffmann-La Roche

Non-Interventional, Prospective Cohort Study of the Effectiveness, Safety and Utilization of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the Management of Genotype 1 Chronic Hepatitis C in Routine Clinical Practice in the USA

This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.

Aperçu de l'étude

Statut

Complété

Les conditions

Hépatite C chronique

Type d'étude

Observationnel

Inscription (Réel)

672

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

Porto Rico
- - San Juan, Porto Rico, 00927
    - Fundacion de Investigacion de Diego
États-Unis
- Alabama
  - Birmingham, Alabama, États-Unis, 35233
    - Cooper Green Hospital
  - Birmingham, Alabama, États-Unis, 35233
    - Univ. of Alabama at Birmingham; The Kirklin Clinic
- Arkansas
  - Little Rock, Arkansas, États-Unis, 72205
    - Liver Wellness Center
- California
  - Loma Linda, California, États-Unis, 92354
    - Loma Linda University Medical Center and Liver Center
  - Pasadena, California, États-Unis, 91105
    - HMRI Liver Center
  - San Diego, California, États-Unis, 92161
    - VA San Diego Healthcare System
  - San Diego, California, États-Unis, 92154
    - Kaiser Permanente San Diego; Hepatology Research
  - Torrance, California, États-Unis, 90505
    - South Bay Gastroenterology Medical Group
- Colorado
  - Aurora, Colorado, États-Unis, 80045
    - University of Colorado Denver
- Connecticut
  - Torrington, Connecticut, États-Unis, 06790
    - Litchfield County Gastroenterology Associates
- Florida
  - Daytona Beach, Florida, États-Unis, 32117
    - Consultive Medicine
  - Largo, Florida, États-Unis, 33777
    - Florida Center for Gastroenterology
  - Maitland, Florida, États-Unis, 32751
    - Center For Advanced Gastroenterology
  - Orlando, Florida, États-Unis, 32806
    - Internal Medicine Specialists
  - Orlando, Florida, États-Unis, 32806
    - Orlando Infectious Disease Center, Pa
  - Tampa, Florida, États-Unis, 33606
    - Tampa General Hospital; Tampa General Medical Group
- Georgia
  - Decatur, Georgia, États-Unis, 30033
    - Atlanta Center for Gastroenterology, PC
  - Decatur, Georgia, États-Unis, 30033
    - Dekalb Gastroenterology Associates
  - Macon, Georgia, États-Unis, 31201
    - Gastroenterology Associates of Central Georgia
- Illinois
  - Chicago, Illinois, États-Unis, 60637
    - University of Chicago
- Indiana
  - Indianapolis, Indiana, États-Unis, 46237
    - Indianapolis Gastroenterology
- Kentucky
  - Crestview Hills, Kentucky, États-Unis, 41017
    - Tristate Gastroenerology Associates
- Louisiana
  - Baton Rouge, Louisiana, États-Unis, 70809
    - Ochsner Clinic Foundation
  - Metairie, Louisiana, États-Unis, 70006
    - New Orleans Research Institute.
  - New Orleans, Louisiana, États-Unis, 70112-2699
    - Tulane Uni Health Sciences Center
- Maryland
  - Baltimore, Maryland, États-Unis, 21202
    - Mercy Medical Center; Institute For Digestive Health And Liver Disease
- Massachusetts
  - Brockton, Massachusetts, États-Unis, 02302
    - Commonwealth Clinical Studies
  - Springfield, Massachusetts, États-Unis, 01199
    - Baystate Infectious Diseases Clinical Research
  - Worcester, Massachusetts, États-Unis, 01068
    - Partners in Internal Medicine
- Michigan
  - Detroit, Michigan, États-Unis, 48201
    - Harper University Hospital/Wayne State
  - Wyoming, Michigan, États-Unis, 49519
    - Gastroenterology Associates of Western Michigan
- Minnesota
  - Rochester, Minnesota, États-Unis, 55905
    - Mayo Clinic Rochester
- Missouri
  - Kansas City, Missouri, États-Unis, 64111
    - St. Luke's Hospital
  - Kansas City, Missouri, États-Unis, 64128
    - Midwest Biomedical Research Foundation
  - St. Louis, Missouri, États-Unis, 63104
    - Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
- New Hampshire
  - Lebanon, New Hampshire, États-Unis, 03756
    - Dartmouth Hitchcock Med Center
- New Jersey
  - Haddon Heights, New Jersey, États-Unis, 08035
    - Lourdes Medical Associates; Southern New Jersey Center for LIver Disease
  - Morristown, New Jersey, États-Unis, 07960
    - Atlantic Research Affiliates
  - Twp, New Jersey, États-Unis, 08234
    - AGA Clinical Research Associates, LLC
- New York
  - Bronx, New York, États-Unis, 10467
    - Montefiore Medical Center
  - Brooklyn, New York, États-Unis, 11215
    - New York Methodist Hospital
  - Catskill, New York, États-Unis, 12414
    - Mountainview Medical Practice
  - Flushing, New York, États-Unis, 11355
    - New Discovery, LLC
  - Manhasset, New York, États-Unis, 11030
    - North Shore University Hospital
  - New York, New York, États-Unis, 10016
    - Concorde Medical Group
  - Rochester, New York, États-Unis, 14642
    - University of Rochester Medical Center
- North Carolina
  - Asheville, North Carolina, États-Unis, 28801
    - Asheville Gastroenterology Associates, P.A.
  - Durham, North Carolina, États-Unis, 27710
    - Duke Univ Medical Center
  - Rocky Mount, North Carolina, États-Unis, 27804
    - Boice-Willis Clinic
- Oklahoma
  - Oklahoma City, Oklahoma, États-Unis, 73112
    - Integris Baptist Medical Center
- Oregon
  - Bend, Oregon, États-Unis, 97701
    - Bend Memorial Clinic
- Pennsylvania
  - DuBois, Pennsylvania, États-Unis, 15801
    - DuBois Regional Medical Center
  - Philadelphia, Pennsylvania, États-Unis, 19107
    - Thomas Jefferson University
  - Philadelphia, Pennsylvania, États-Unis, 19140
    - Temple University Hospital
  - Philadelphia, Pennsylvania, États-Unis, 19141
    - Albert Einstein Medical Center; Division of Hepatology
- Tennessee
  - Memphis, Tennessee, États-Unis, 38104
    - Methodist Heathcare University Hospital
- Texas
  - Austin, Texas, États-Unis, 78758
    - Imtiaz Alam MD, P.A. - Private Practice
  - Dallas, Texas, États-Unis, 75203
    - Methodist Transplant Physicians
  - Galveston, Texas, États-Unis, 77555
    - Univ of Texas Medical Branch
  - Houston, Texas, États-Unis, 77005
    - Kelsey Research Foundation
  - Houston, Texas, États-Unis, 77030
    - Liver Associates of Texas
  - Houston, Texas, États-Unis, 77090
    - Digestive And Liver Disease Consultants, PA
- Vermont
  - Burlington, Vermont, États-Unis, 5401
    - University of Vermont
- Virginia
  - Charlottesville, Virginia, États-Unis, 22908
    - University of Virginia Health System: Gastroenterology at UVA
  - Fairfax, Virginia, États-Unis, 22031
    - Metropolitan Research

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 et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Patients with chronic hepatitis C genotype 1 receiving pegylated interferon-based direct acting antiviral triple therapies in the US

La description

Inclusion Criteria:

Adult patients, >/= 18 years of age
Chronic hepatitis C, genotype 1
Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling

Exclusion Criteria:

Contraindications per US labels

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

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Cohorte

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Time to Premature Treatment Discontinuation Due to Any Reason Délai: Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)	Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.	Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)
Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period Délai: 12 weeks or later post-completion of the treatment period	SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period	12 weeks or later post-completion of the treatment period

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Number of Participants With Virologic Response (VR) Délai: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period	VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)	Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above Délai: Weeks 2, 4, 8, and 12	VRVR was defined as HCV RNA < 50 IU/mL at treatment Week 2; RVR as HCV RNA < 50 IU/mL by treatment Week 4, but no HCV RNA < 50 IU/mL at Week 2; Week 8 VR as HCV RNA < 50 IU/mL by study Week 8 but no HCV RNA < 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA < 50 IU/mL by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 12.	Weeks 2, 4, 8, and 12
Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder Délai: Up to Week 48	The extended VR is defined as initial HCV RNA < 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA < 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by >=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA < 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.	Up to Week 48
Predictors of Sustained Virologic Response by Week Délai: Weeks 2, 4, 6, 8, and 12	SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA < 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA < 50 IU/mL or unquantifiable or HCV-RNA >=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.	Weeks 2, 4, 6, 8, and 12
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Délai: Week 12	Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease < 2 log10 at Week 12), partial responder (HCV RNA decrease > 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant's choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.	Week 12
Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment Délai: Up to Week 48	The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant's first date of undetectable HCV RNA and the date of the participant's last dose.	Up to Week 48
Time to Premature Treatment Discontinuation Due to Lack of Efficacy Délai: Up to Week 48	The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.	Up to Week 48
Time to Premature Treatment Discontinuation Due to Intolerance Délai: Up to Week 48	The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.	Up to Week 48
Treatment Duration, as Measure of Extent of Exposure to Study Medication Délai: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication Délai: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication Délai: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Compliance of Study Treatment Délai: Weeks 4, 8, 12, and 24	Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.	Weeks 4, 8, 12, and 24
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label Délai: Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)	As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label Délai: Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)	As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.	Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)
Number of Participants With Safety-related Dose Reductions Délai: Up to 48 weeks	The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.	Up to 48 weeks
Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs) Délai: Up to 48 weeks	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	Up to 48 weeks
Number of Participants With Any AEs and Serious Adverse Events (SAEs) Délai: Up to 12 weeks post-treatment	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.	Up to 12 weeks post-treatment
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Délai: Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment	WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.	Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

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 (Réel)

31 janvier 2012

Achèvement primaire (Réel)

31 mars 2014

Achèvement de l'étude (Réel)

31 mars 2014

Dates d'inscription aux études

Première soumission

9 janvier 2012

Première soumission répondant aux critères de contrôle qualité

9 janvier 2012

Première publication (Estimation)

11 janvier 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 mars 2017

Dernière vérification

1 mars 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

ML27900

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 .

Essais cliniques sur Hépatite C chronique

Pfizer

Complété

Une étude ouverte multicentrique de phase 3 comparant le bosutinib à l'imatinib chez des patients adultes atteints d'une leucémie myéloïde chronique en phase chronique nouvellement diagnostiquée

Leucémie, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positif

France, États-Unis, Canada, Espagne, Tchéquie, Singapour, Thaïlande, Danemark, Norvège, Corée, République de, Finlande, Hongrie, Suède, Pays-Bas, Italie, Allemagne, Ukraine, Afrique du Sud, Taïwan, Australie, Belgique, Israël, Mexique, Pologn... et plus