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

10 de marzo de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

672

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Grupo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Premature Treatment Discontinuation Due to Any Reason
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Virologic Response (VR)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hoffmann-La Roche

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de enero de 2012

Finalización primaria (Actual)

31 de marzo de 2014

Finalización del estudio (Actual)

31 de marzo de 2014

Fechas de registro del estudio

Enviado por primera vez

9 de enero de 2012

Primero enviado que cumplió con los criterios de control de calidad

9 de enero de 2012

Publicado por primera vez (Estimar)

11 de enero de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

10 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ML27900

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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