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
NCT ID: NCT01066819
Last Updated: 2016-08-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1656 participants
OBSERVATIONAL
2008-01-31
2011-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
NCT01066793
PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)
NCT01070550
An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C
NCT01679834
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy
NCT01416610
A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy
NCT01337375
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort
Participants chronically infected with the hepatitis C virus including genotypes 1 to 6.
Peginterferon alfa-2a [Pegasys]
Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Peginterferon alfa-2b [PegIntron®]
Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peginterferon alfa-2a [Pegasys]
Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Peginterferon alfa-2b [PegIntron®]
Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* chronic hepatitis C
* HIV HCV co-infection allowed
* informed consent to data collection
Exclusion Criteria
* previous treatment with peginterferon and/or ribavirin
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Camp Hill, Pennsylvania, United States
DuBois, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
West Nashville, Tennessee, United States
Dallas, Texas, United States
Galveston, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Huntington, West Virginia, United States
Casper, Wyoming, United States
Santurce, , Puerto Rico
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Dothan, Alabama, United States
Fresno, California, United States
La Jolla, California, United States
Lancaster, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Clemente, California, United States
San Diego, California, United States
San Francisco, California, United States
San Mateo, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
Gainesville, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Opelousas, Louisiana, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Topeka, Missouri, United States
Lebanon, New Hampshire, United States
Egg Harbour Township, New Jersey, United States
Hackensack, New Jersey, United States
Hillsborough, New Jersey, United States
Roseland, New Jersey, United States
Voorhees Township, New Jersey, United States
Albuquerque, New Mexico, United States
Bayside, New York, United States
Catskill, New York, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Fayetteville, North Carolina, United States
Rocky Mount, North Carolina, United States
Winston-Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MV21542
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.