Clinical trial NCT01066819: PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
Official title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 1656
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 receiving peginterferon alfa treatment at a medical centre

Brief summary: This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<2000.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic hepatitis C
* HIV HCV co-infection allowed
* informed consent to data collection

Exclusion Criteria:

* co-infection with Hepatitis B Virus (HBV)
* previous treatment with peginterferon and/or ribavirin

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
timeFrame: At 24 weeks (Wk) after EOT
measure: Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
timeFrame: At 24 weeks after EOT
Secondary outcomes:
measure: Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
timeFrame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
measure: Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
timeFrame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
measure: Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time
timeFrame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
measure: Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time
timeFrame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
measure: Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
timeFrame: At Week 2, Week 4 and Week 12
measure: Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12
timeFrame: At Week 2, Week 4 and Week 12
measure: Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12
timeFrame: At Week 2, Week 4 and Week 12
measure: Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12
timeFrame: At Week 2, Week 4 and Week 12
measure: Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
timeFrame: At 24 weeks after EOT
measure: Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12
timeFrame: At Week 4 and Week 12
measure: Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12
timeFrame: During first 12 weeks of treatment
measure: Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment
timeFrame: At 12 weeks after EOT
measure: Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment
timeFrame: 24 weeks after EOT
measure: Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment
timeFrame: At 12 weeks after EOT
measure: Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment
timeFrame: At 24 weeks after EOT
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Dothan
country: United States
state: Alabama
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Clemente
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Gainesville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Opelousas
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Topeka
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Egg Harbour Township
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Hillsborough
country: United States
state: New Jersey
city: Roseland
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bayside
country: United States
state: New York
city: Catskill
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Rocky Mount
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Camp Hill
country: United States
state: Pennsylvania
city: DuBois
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: West Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Harlingen
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: Casper
country: United States
state: Wyoming
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ferenci P, Aires R, Ancuta I, Arohnson A, Cheinquer H, Delic D, Gschwantler M, Larrey D, Tallarico L, Schmitz M, Tatsch F, Ouzan D. A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin. Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.