Clinical trial NCT01066793: 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
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: 2343
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
* informed consent to data collection

Exclusion Criteria:

* co-infection with HIV or 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 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 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 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
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 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 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 12 Weeks after EOT
measure: Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time
timeFrame: At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT
measure: Percentage of Participants With at Least a 2-logarithm10 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-logarithm10 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-logarithm10 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-logarithm 10 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: 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: 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: At Week 4 and Week 12
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 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 Modified All-Treated Population at 24 Weeks After End of Treatment
timeFrame: At 24 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: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Gilly (Charleroi)
country: Belgium
city: Godinne
country: Belgium
city: Haine-Saint-Paul
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Namur
country: Belgium
city: Oostende
country: Belgium
city: Roeselare
country: Belgium
city: Seraing
country: Belgium
city: Sijsele
country: Belgium
city: Tielt
country: Belgium
city: Verviers
country: Belgium
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Pescara
country: Italy
state: Abruzzo
city: Catanzaro
country: Italy
state: Calabria
city: Vibo Valentia
country: Italy
state: Calabria
city: Barra
country: Italy
state: Campania
city: Benevento
country: Italy
state: Campania
city: Gragnano
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Nola
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Ferrara
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Basovizza (TS)
country: Italy
state: Friuli-Venezia Giulia
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Savona
country: Italy
state: Liguria
city: Brescia
country: Italy
state: Lombardia
city: Busto Arsizio
country: Italy
state: Lombardia
city: Cremona
country: Italy
state: Lombardia
city: Lecco
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Saronno
country: Italy
state: Lombardia
city: Treviglio
country: Italy
state: Lombardia
city: Fermo
country: Italy
state: Marche
city: Isernia
country: Italy
state: Molise
city: Alessandria
country: Italy
state: Piemonte
city: Asti
country: Italy
state: Piemonte
city: Biella
country: Italy
state: Piemonte
city: Novara
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Bisceglie
country: Italy
state: Puglia
city: Brindisi
country: Italy
state: Puglia
city: Casarano
country: Italy
state: Puglia
city: Castellana Grotte
country: Italy
state: Puglia
city: Foggia
country: Italy
state: Puglia
city: Galatina
country: Italy
state: Puglia
city: Taranto
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Comiso
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Arezzo
country: Italy
state: Toscana
city: Firenze
country: Italy
state: Toscana
city: Grosseto
country: Italy
state: Toscana
city: Bolzano
country: Italy
state: Trentino-Alto Adige
city: Trento
country: Italy
state: Trentino-Alto Adige
city: Perugia
country: Italy
state: Umbria
city: Mestre (VE)
country: Italy
state: Veneto
city: Padova
country: Italy
state: Veneto
city: Treviso
country: Italy
state: Veneto
city: Venezia
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
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.