Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

10 de março de 2017 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Hepatite C Crônica

Tipo de estudo

Observacional

Inscrição (Real)

672

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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
Porto Rico
- - San Juan, Porto Rico, 00927
    - Fundacion De Investigacion de Diego

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
Coorte

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Time to Premature Treatment Discontinuation Due to Any Reason Prazo: 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 Prazo: 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 resultados secundários

Medida de resultado	Descrição da medida	Prazo
Number of Participants With Virologic Response (VR) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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) Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

31 de janeiro de 2012

Conclusão Primária (Real)

31 de março de 2014

Conclusão do estudo (Real)

31 de março de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

9 de janeiro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ