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

NCT ID: NCT01508130

Last Updated: 2017-04-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

672 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Cooper Green Hospital

Birmingham, Alabama, United States

Site Status

Univ. of Alabama at Birmingham; The Kirklin Clinic

Birmingham, Alabama, United States

Site Status

Liver Wellness Center

Little Rock, Arkansas, United States

Site Status

Loma Linda University Medical Center and Liver Center

Loma Linda, California, United States

Site Status

HMRI Liver Center

Pasadena, California, United States

Site Status

Kaiser Permanente San Diego; Hepatology Research

San Diego, California, United States

Site Status

VA San Diego Healthcare System

San Diego, California, United States

Site Status

South Bay Gastroenterology Medical Group

Torrance, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

Litchfield County Gastroenterology Associates

Torrington, Connecticut, United States

Site Status

Consultive Medicine

Daytona Beach, Florida, United States

Site Status

Florida Center for Gastroenterology

Largo, Florida, United States

Site Status

Center for Advanced Gastroenterology

Maitland, Florida, United States

Site Status

Internal Medicine Specialists

Orlando, Florida, United States

Site Status

Orlando Infectious Disease Center, Pa

Orlando, Florida, United States

Site Status

Tampa General Hospital; Tampa General Medical Group

Tampa, Florida, United States

Site Status

Atlanta Center for Gastroenterology, PC

Decatur, Georgia, United States

Site Status

Dekalb Gastroenterology Associates

Decatur, Georgia, United States

Site Status

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Indianapolis Gastroenterology

Indianapolis, Indiana, United States

Site Status

Tristate Gastroenerology Associates

Crestview Hills, Kentucky, United States

Site Status

Ochsner Clinic Foundation

Baton Rouge, Louisiana, United States

Site Status

New Orleans Research Institute.

Metairie, Louisiana, United States

Site Status

Tulane Uni Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Mercy Medical Center; Institute For Digestive Health And Liver Disease

Baltimore, Maryland, United States

Site Status

Commonwealth Clinical Studies

Brockton, Massachusetts, United States

Site Status

Baystate Infectious Diseases Clinical Research

Springfield, Massachusetts, United States

Site Status

Partners in Internal Medicine

Worcester, Massachusetts, United States

Site Status

Harper University Hospital/Wayne State

Detroit, Michigan, United States

Site Status

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

St. Luke's Hospital

Kansas City, Missouri, United States

Site Status

Midwest Biomedical Research Foundation

Kansas City, Missouri, United States

Site Status

Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Med Center

Lebanon, New Hampshire, United States

Site Status

Lourdes Medical Associates; Southern New Jersey Center for LIver Disease

Haddon Heights, New Jersey, United States

Site Status

Atlantic Research Affiliates

Morristown, New Jersey, United States

Site Status

AGA Clinical Research Associates, LLC

Twp, New Jersey, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

Mountainview Medical Practice

Catskill, New York, United States

Site Status

New Discovery, LLC

Flushing, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Concorde Medical Group

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, United States

Site Status

Duke Univ Medical Center

Durham, North Carolina, United States

Site Status

Boice-Willis Clinic

Rocky Mount, North Carolina, United States

Site Status

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Bend Memorial Clinic

Bend, Oregon, United States

Site Status

DuBois Regional Medical Center

DuBois, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Albert Einstein Medical Center; Division of Hepatology

Philadelphia, Pennsylvania, United States

Site Status

Methodist Heathcare University Hospital

Memphis, Tennessee, United States

Site Status

Imtiaz Alam MD, P.A. - Private Practice

Austin, Texas, United States

Site Status

Methodist Transplant Physicians

Dallas, Texas, United States

Site Status

Univ of Texas Medical Branch

Galveston, Texas, United States

Site Status

Kelsey Research Foundation

Houston, Texas, United States

Site Status

Liver Associates of Texas

Houston, Texas, United States

Site Status

Digestive And Liver Disease Consultants, PA

Houston, Texas, United States

Site Status

University of Vermont

Burlington, Vermont, United States

Site Status

University of Virginia Health System: Gastroenterology at UVA

Charlottesville, Virginia, United States

Site Status

Metropolitan Research

Fairfax, Virginia, United States

Site Status

Fundacion de Investigacion de Diego

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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ML27900

Identifier Type: -

Identifier Source: org_study_id

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