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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. März 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

672

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Kohorte

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Premature Treatment Discontinuation Due to Any Reason
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Virologic Response (VR)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. Januar 2012

Primärer Abschluss (Tatsächlich)

31. März 2014

Studienabschluss (Tatsächlich)

31. März 2014

Studienanmeldedaten

Zuerst eingereicht

9. Januar 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Januar 2012

Zuerst gepostet (Schätzen)

11. Januar 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. März 2017

Zuletzt verifiziert

1. März 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ML27900

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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