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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 марта 2017 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Тип исследования

Наблюдательный

Регистрация (Действительный)

672

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

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

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Когорта

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Time to Premature Treatment Discontinuation Due to Any Reason
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Virologic Response (VR)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hoffmann-La Roche

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

31 января 2012 г.

Первичное завершение (Действительный)

31 марта 2014 г.

Завершение исследования (Действительный)

31 марта 2014 г.

Даты регистрации исследования

Первый отправленный

9 января 2012 г.

Впервые представлено, что соответствует критериям контроля качества

9 января 2012 г.

Первый опубликованный (Оценивать)

11 января 2012 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

10 апреля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 марта 2017 г.

Последняя проверка

1 марта 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ML27900

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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