Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

perjantai 10. maaliskuuta 2017 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

672

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Todennäköisyysnäyte

Tutkimusväestö

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

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Kohortti

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time to Premature Treatment Discontinuation Due to Any Reason
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Virologic Response (VR)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hoffmann-La Roche

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 31. tammikuuta 2012

Ensisijainen valmistuminen (Todellinen)

Maanantai 31. maaliskuuta 2014

Opintojen valmistuminen (Todellinen)

Maanantai 31. maaliskuuta 2014

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 9. tammikuuta 2012

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 9. tammikuuta 2012

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 11. tammikuuta 2012

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 10. huhtikuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 10. maaliskuuta 2017

Viimeksi vahvistettu

Keskiviikko 1. maaliskuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • ML27900

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Hepatiitti C, krooninen

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Congo

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

3
Tilaa