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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

2017년 3월 10일 업데이트: 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.

연구 개요

상태

완전한

정황

만성 C형 간염

연구 유형

관찰

등록 (실제)

672

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
보병대

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Time to Premature Treatment Discontinuation Due to Any Reason 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Number of Participants With Virologic Response (VR) 기간: 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 기간: 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 기간: 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 기간: 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) 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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) 기간: 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) 기간: 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) 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2012년 1월 31일

기본 완료 (실제)

2014년 3월 31일

연구 완료 (실제)

2014년 3월 31일

연구 등록 날짜

최초 제출

2012년 1월 9일

QC 기준을 충족하는 최초 제출