Clinical trial NCT01508130: An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C genotype 1 receiving pegylated interferon-based direct acting antiviral triple therapies in the US

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Premature Treatment Discontinuation Due to Any Reason
timeFrame: 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)
measure: Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period
timeFrame: 12 weeks or later post-completion of the treatment period
Secondary outcomes:
measure: Number of Participants With Virologic Response (VR)
timeFrame: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period
measure: 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
timeFrame: Weeks 2, 4, 8, and 12
measure: Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder
timeFrame: Up to Week 48
measure: Predictors of Sustained Virologic Response by Week
timeFrame: Weeks 2, 4, 6, 8, and 12
measure: Number of Participants With SVR by Subgroups (Demographic and Baseline Factors)
timeFrame: Week 12
measure: Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment
timeFrame: Up to Week 48
measure: Time to Premature Treatment Discontinuation Due to Lack of Efficacy
timeFrame: Up to Week 48
measure: Time to Premature Treatment Discontinuation Due to Intolerance
timeFrame: Up to Week 48
measure: Treatment Duration, as Measure of Extent of Exposure to Study Medication
timeFrame: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
measure: Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication
timeFrame: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
measure: Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication
timeFrame: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
measure: Compliance of Study Treatment
timeFrame: Weeks 4, 8, 12, and 24
measure: Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label
timeFrame: Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)
measure: Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label
timeFrame: 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)
measure: Number of Participants With Safety-related Dose Reductions
timeFrame: Up to 48 weeks
measure: Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs)
timeFrame: Up to 48 weeks
measure: Number of Participants With Any AEs and Serious Adverse Events (SAEs)
timeFrame: Up to 12 weeks post-treatment
measure: Change From Baseline in Work Loss And Productivity Outcomes (WPAI)
timeFrame: Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cooper Green Hospital
state: Alabama
city: Birmingham
country: United States
facility: Univ. of Alabama at Birmingham; The Kirklin Clinic
state: Alabama
city: Little Rock
country: United States
facility: Liver Wellness Center
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center and Liver Center
state: California
city: Pasadena
country: United States
facility: HMRI Liver Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego; Hepatology Research
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Torrance
country: United States
facility: South Bay Gastroenterology Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Torrington
country: United States
facility: Litchfield County Gastroenterology Associates
state: Connecticut
city: Daytona Beach
country: United States
facility: Consultive Medicine
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Maitland
country: United States
facility: Center for Advanced Gastroenterology
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Orlando
country: United States
facility: Orlando Infectious Disease Center, Pa
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital; Tampa General Medical Group
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, PC
state: Georgia
city: Decatur
country: United States
facility: Dekalb Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology
state: Indiana
city: Crestview Hills
country: United States
facility: Tristate Gastroenerology Associates
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Metairie
country: United States
facility: New Orleans Research Institute.
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Uni Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center; Institute For Digestive Health And Liver Disease
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Infectious Diseases Clinical Research
state: Massachusetts
city: Worcester
country: United States
facility: Partners in Internal Medicine
state: Massachusetts
city: Detroit
country: United States
facility: Harper University Hospital/Wayne State
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: Midwest Biomedical Research Foundation
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Med Center
state: New Hampshire
city: Haddon Heights
country: United States
facility: Lourdes Medical Associates; Southern New Jersey Center for LIver Disease
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Research Affiliates
state: New Jersey
city: Twp
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Catskill
country: United States
facility: Mountainview Medical Practice
state: New York
city: Flushing
country: United States
facility: New Discovery, LLC
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Durham
country: United States
facility: Duke Univ Medical Center
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic
state: North Carolina
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: DuBois
country: United States
facility: DuBois Regional Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center; Division of Hepatology
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist Heathcare University Hospital
state: Tennessee
city: Austin
country: United States
facility: Imtiaz Alam MD, P.A. - Private Practice
state: Texas
city: Dallas
country: United States
facility: Methodist Transplant Physicians
state: Texas
city: Galveston
country: United States
facility: Univ of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Kelsey Research Foundation
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas
state: Texas
city: Houston
country: United States
facility: Digestive And Liver Disease Consultants, PA
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health System: Gastroenterology at UVA
state: Virginia
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: