Clinical trial NCT01070550: 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)
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: 2010-02-18
Enrollment: 4680
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-2a 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) 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 \<5000.


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

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With Modified Sustained Virological Response by 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 Week 12 on Modified Sustained Virological Response by Genotype 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 by Genotype After Treatment Initiation in Per-Protocol Population
timeFrame: At 24 weeks after EOT
Secondary outcomes:
measure: Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time
timeFrame: At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT
measure: Percentage of Participants With Virological Response by 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 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 by 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 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype 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 Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12
timeFrame: Week 2, Week 4, and Week 12
measure: Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12
timeFrame: Week 2, Week 4, and Week 12
measure: Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12
timeFrame: Week 2, Week 4, and Week 12
measure: Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12
timeFrame: Week 4 and Week 12
measure: Number of Participants With Response by Disjoint Categories by Genotype 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
measure: Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype 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 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population
timeFrame: At 24 weeks after EOT
Other outcomes:
Locations:
city: Gratwein
country: Austria
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Salvador
country: Brazil
state: BA
city: Goiania
country: Brazil
state: GO
city: Belo Horizonte
country: Brazil
state: MG
city: Belem
country: Brazil
state: PA
city: Recife
country: Brazil
state: PE
city: Recife
country: Brazil
state: PE
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Rio Grande
country: Brazil
state: RS
city: Botucatu
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Santos
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Nanaimo
country: Canada
state: British Columbia
city: New Westminster
country: Canada
state: British Columbia
city: Prince George
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Barrie
country: Canada
state: Ontario
city: Brampton
country: Canada
state: Ontario
city: Etobicoke
country: Canada
state: Ontario
city: Guelph
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Levis
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Saint-jean Sur Richelieu
country: Canada
state: Quebec
city: St-charles Borromee
country: Canada
state: Quebec
city: Osijek
country: Croatia
city: Pula
country: Croatia
city: Split
country: Croatia
city: Zadar
country: Croatia
city: Zagreb
country: Croatia
city: Agen
country: France
city: Aix En Provence
country: France
city: Albi
country: France
city: Amiens
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city: Angers
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city: Annecy
country: France
city: Antibes
country: France
city: Argenteuil
country: France
city: Argenteuil
country: France
city: Aulnay Sous Bois
country: France
city: Aulnay Sous Bois
country: France
city: Bastia
country: France
city: Beaumont
country: France
city: Beausoleil
country: France
city: Beauvais
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city: Besancon
country: France
city: Besancon
country: France
city: Beziers
country: France
city: Beziers
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne Billancourt
country: France
city: Bourgoin Jallieu
country: France
city: Caen
country: France
city: Chambery
country: France
city: Clermont Ferrand
country: France
city: Clichy
country: France
city: Colmar
country: France
city: Cornebarrieu
country: France
city: Creil
country: France
city: Creteil
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Dijon
country: France
city: Druex
country: France
city: Evreux
country: France
city: Frejus
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city: Freyming Merlebach
country: France
city: Grasse
country: France
city: Grenoble
country: France
city: Herouville St Clair
country: France
city: Hyeres
country: France
city: La Rochelle
country: France
city: La Valette du Var
country: France
city: Lagny Sur Marne
country: France
city: Le Chesnay
country: France
city: Le Havre
country: France
city: Le Kremlin Bicetre
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lomme
country: France
city: Lorient
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Martigues
country: France
city: Meaux
country: France
city: Melun
country: France
city: Menton
country: France
city: Metz
country: France
city: Metz
country: France
city: Monaco
country: France
city: Montauban
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Muret
country: France
city: Nanterre
country: France
city: Nantes
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nice
country: France
city: Nimes
country: France
city: Nimes
country: France
city: Ollioules
country: France
city: Orange
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perigueux
country: France
city: Perpignan
country: France
city: Pessac
country: France
city: Poissy
country: France
city: Poitiers
country: France
city: Pont a Mousson
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Laurent Du Var
country: France
city: Sete
country: France
city: St Dizier
country: France
city: St Jean De Verges
country: France
city: St Mande
country: France
city: Ste Maxime
country: France
city: Strasbourg
country: France
city: Tarbes
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city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Villejuif
country: France
city: Ajka
country: Hungary
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Kistarcsa
country: Hungary
city: Miskolc
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Székesfehérvár
country: Hungary
city: Tatabánya
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Chihuahua
country: Mexico
city: Chihuahua
country: Mexico
city: Culiacan
country: Mexico
city: Guadalajara
country: Mexico
city: Hermosillo
country: Mexico
city: Mexicali
country: Mexico
city: Mexico City
country: Mexico
city: Mexico DF
country: Mexico
city: Monterrey
country: Mexico
city: Puebla
country: Mexico
city: Puebla
country: Mexico
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Rabat
country: Morocco
city: Bydgoszcz
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Arad
country: Romania
city: Brasov
country: Romania
city: Brasov
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Constanta
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Iasi
country: Romania
city: Sector 2
country: Romania
city: Targu-Mures
country: Romania
city: Timisoara
country: Romania
city: Timisoara
country: Romania
city: Belgrade
country: Serbia
city: NIS
country: Serbia
city: Novi Sad
country: Serbia
city: Celje
country: Slovenia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Novo Mesto
country: Slovenia
city: Eskilstuna
country: Sweden
city: Halmstad
country: Sweden
city: Huddinge
country: Sweden
city: Linkoeping
country: Sweden
city: Lund
country: Sweden
city: Oerebro
country: Sweden
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.