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
NCT ID: NCT01066793
Last Updated: 2016-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
2343 participants
OBSERVATIONAL
2007-10-31
2011-05-31
Brief Summary
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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
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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)
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An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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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
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Inclusion Criteria
* chronic hepatitis C
* informed consent to data collection
Exclusion Criteria
* previous treatment with peginterferon and/or ribavirin
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Aalst, , Belgium
Antwerp, , Belgium
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Charleroi, , Belgium
Edegem, , Belgium
Genk, , Belgium
Ghent, , Belgium
Gilly (Charleroi), , Belgium
Godinne, , Belgium
Haine-Saint-Paul, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Namur, , Belgium
Ostend, , Belgium
Roeselare, , Belgium
Seraing, , Belgium
Sijsele, , Belgium
Tielt, , Belgium
Verviers, , Belgium
Dublin, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Pescara, Abruzzo, Italy
Bisceglie, Apulia, Italy
Brindisi, Apulia, Italy
Casarano, Apulia, Italy
Castellana Grotte, Apulia, Italy
Foggia, Apulia, Italy
Galatina, Apulia, Italy
Taranto, Apulia, Italy
Catanzaro, Calabria, Italy
Vibo Valentia, Calabria, Italy
Barra, Campania, Italy
Benevento, Campania, Italy
Gragnano, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Nola, Campania, Italy
Bologna, Emilia-Romagna, Italy
Ferrara, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Basovizza (TS), Friuli Venezia Giulia, Italy
Udine, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Savona, Liguria, Italy
Brescia, Lombardy, Italy
Busto Arsizio, Lombardy, Italy
Cremona, Lombardy, Italy
Lecco, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Monza, Lombardy, Italy
Saronno, Lombardy, Italy
Treviglio, Lombardy, Italy
Isernia, Molise, Italy
Alessandria, Piedmont, Italy
Asti, Piedmont, Italy
Biella, Piedmont, Italy
Novara, Piedmont, Italy
Turin, Piedmont, Italy
Turin, Piedmont, Italy
Cagliari, Sardinia, Italy
Catania, Sicily, Italy
Comiso, Sicily, Italy
Palermo, Sicily, Italy
Fermo, The Marches, Italy
Bolzano, Trentino-Alto Adige, Italy
Trento, Trentino-Alto Adige, Italy
Arezzo, Tuscany, Italy
Florence, Tuscany, Italy
Grosseto, Tuscany, Italy
Perugia, Umbria, Italy
Mestre (VE), Veneto, Italy
Padua, Veneto, Italy
Treviso, Veneto, Italy
Venezia, Veneto, Italy
Verona, Veneto, Italy
London, , United Kingdom
Countries
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References
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Ascione A, Bruno S, Coppola C, Mangia A, Orlandini A, Schmitz M, Deodato B, Puoti M. Treatment Outcomes and Predictors of Response in Treatment-Naive HCV Patients Treated with Peginterferon Alfa/Ribavirin in Real-World Italian Clinics: Sub-Analysis from the PROPHESYS Cohort. Hepatogastroenterology. 2014 Jun;61(132):1094-106.
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
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MV21020
Identifier Type: -
Identifier Source: org_study_id
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