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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

2017年3月10日 更新者：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.

調査の概要

状態

完了

条件

研究の種類

観察的

入学 (実際)

672

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
コホート

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to Premature Treatment Discontinuation Due to Any Reason
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Virologic Response (VR)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hoffmann-La Roche

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2012年1月31日

一次修了 (実際)

2014年3月31日

研究の完了 (実際)

2014年3月31日

試験登録日

最初に提出

2012年1月9日

QC基準を満たした最初の提出物

2012年1月9日

最初の投稿 (見積もり)

2012年1月11日

学習記録の更新

投稿された最後の更新 (実際)

2017年4月10日

QC基準を満たした最後の更新が送信されました

2017年3月10日

最終確認日

2017年3月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • ML27900

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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