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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 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

672

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Coorte

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Premature Treatment Discontinuation Due to Any Reason
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Virologic Response (VR)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 gennaio 2012

Completamento primario (Effettivo)

31 marzo 2014

Completamento dello studio (Effettivo)

31 marzo 2014

Date di iscrizione allo studio

Primo inviato

9 gennaio 2012

Primo inviato che soddisfa i criteri di controllo qualità

9 gennaio 2012

Primo Inserito (Stima)

11 gennaio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ML27900

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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