Clinical trial NCT01447446: An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
Official title: Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 4442
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: Chronic hepatitis C (CHC) participants (naïve or treatment experienced, including HIV HCV co-infected) receiving combination therapy with pegylated interferons plus ribavirin or treatment regimens containing direct-acting antivirals.

Brief summary: This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult (according to local legislation) participants
* Chronic hepatitis C (HCV)
* Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected
* Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling

Exclusion Criteria:

* Contraindications according to SPC/local labeling
* Treatment started \>4 weeks before entering study

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
timeFrame: 24 weeks after end of treatment (up to 118 weeks)
measure: Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
timeFrame: 12 weeks after end of treatment (up to 118 weeks)
Secondary outcomes:
measure: Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
timeFrame: Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
measure: Virological Relapse After End of Treatment
timeFrame: Up to 24 weeks after EOT (up to 118 weeks)
measure: Virological Breakthrough
timeFrame: Up to EOT (up to 118 weeks)
measure: Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
timeFrame: Up to first 12 weeks of treatment
measure: Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks
timeFrame: Up to 12 weeks
measure: Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
timeFrame: Up to 98 weeks
measure: Duration of Overall Treatment
timeFrame: Up to 118 weeks
measure: Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
timeFrame: Up to 118 weeks
measure: Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
timeFrame: Up to 72 weeks of treatment
measure: Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
timeFrame: Up to 72 weeks of treatment
measure: Percentage of Participants With Concomitant Medical Condition at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Adverse Events (AE)
timeFrame: Up to 118 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Antwerpen
country: Belgium
city: Bouge
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: Edegem
country: Belgium
city: Gent
country: Belgium
city: Gilly (Charleroi)
country: Belgium
city: Hasselt
country: Belgium
city: Heusy
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Mons
country: Belgium
city: Montignies sur Sambre
country: Belgium
city: Namur
country: Belgium
city: Oostende
country: Belgium
city: Roeselare
country: Belgium
city: Verviers
country: Belgium
city: Alexandria
country: Egypt
city: Alexandria
country: Egypt
city: Cairo
country: Egypt
city: Cairo
country: Egypt
city: Giza
country: Egypt
city: Tanta
country: Egypt
city: Kohtla-Järve
country: Estonia
city: Pärnu
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Aix En Provence
country: France
city: Amiens
country: France
city: Argenteuil
country: France
city: Avignon
country: France
city: Besancon
country: France
city: Besancon
country: France
city: Beziers
country: France
city: Boulogne Billancourt
country: France
city: Bourgoin Jallieu
country: France
city: Caen
country: France
city: Chambray Les Tours
country: France
city: Clichy
country: France
city: Creil
country: France
city: Creteil
country: France
city: Epinay-Sur-Seine
country: France
city: Evry
country: France
city: Freyming Merlebach
country: France
city: Gonesse
country: France
city: Grasse
country: France
city: Hyeres
country: France
city: La Tronche
country: France
city: Lagny Sur Marne
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lomme
country: France
city: Lyon
country: France
city: Mantes La Jolie
country: France
city: Marseille
country: France
city: Meaux
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Nimes
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: Pau
country: France
city: Perpignan
country: France
city: Pessac
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Nazaire
country: France
city: St Laurent Du Var
country: France
city: St Priest En Jarez
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Villejuif
country: France
city: Villeneuve Maguelone
country: France
city: Villeneuve St Georges
country: France
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Burghausen
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Kassel
country: Germany
city: Köln
country: Germany
city: Lübeck
country: Germany
city: Magdeburg
country: Germany
city: Mannheim
country: Germany
city: Rostock
country: Germany
city: Rottenburg
country: Germany
city: Tübingen
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Larissa
country: Greece
city: Nea Kifissia
country: Greece
city: Patra
country: Greece
city: Thessaloniki
country: Greece
city: Ajka
country: Hungary
city: Balassagyarmat
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: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Sopron
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
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: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Chieti
country: Italy
state: Abruzzo
city: Reggio Calabria
country: Italy
state: Calabria
city: Avellino
country: Italy
state: Campania
city: Gragnano
country: Italy
state: Campania
city: Marcianise
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Nocera Inferiore
country: Italy
state: Campania
city: Nola
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Piacenza
country: Italy
state: Emilia-Romagna
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: Genova
country: Italy
state: Liguria
city: Savona
country: Italy
state: Liguria
city: Busto Arsizio
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: Milano
country: Italy
state: Lombardia
city: Torrette Di Ancona
country: Italy
state: Marche
city: Biella
country: Italy
state: Piemonte
city: Cuorgnè (TO)
country: Italy
state: Piemonte
city: Omegna (VB)
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Bisceglie
country: Italy
state: Puglia
city: Castellana Grotte
country: Italy
state: Puglia
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Cagliari
country: Italy
state: Sardegna
city: Sassari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Catania
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Arezzo
country: Italy
state: Toscana
city: Firenze
country: Italy
state: Toscana
city: Livorno
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Safat
country: Kuwait
city: Baabda
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Nabatieh
country: Lebanon
city: Tripoli
country: Lebanon
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Fes
country: Morocco
city: Marrakech
country: Morocco
city: Rabat
country: Morocco
city: Rabat
country: Morocco
city: Muscat
country: Oman
city: Faisalabad
country: Pakistan
city: Gujranwala
country: Pakistan
city: Karachi
country: Pakistan
city: Lahore
country: Pakistan
city: Lahore
country: Pakistan
city: Rawalpindi
country: Pakistan
city: Almada
country: Portugal
city: Amadora
country: Portugal
city: Aveiro
country: Portugal
city: Beja
country: Portugal
city: Coimbra
country: Portugal
city: Faro
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Doha
country: Qatar
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Holy Makkah
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
city: Belgrade
country: Serbia
city: Novi Sad
country: Serbia
city: Gävle
country: Sweden
city: Karlstad
country: Sweden
city: Uppsala
country: Sweden
city: Lugano
country: Switzerland
city: St. Gallen
country: Switzerland
city: Aleppo
country: Syrian Arab Republic
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Hatay
country: Turkey
city: ISTANBULt
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Mersin
country: Turkey
city: Tokat
country: Turkey
city: Trabzon
country: Turkey
city: Al Ain
country: United Arab Emirates
city: Dubai
country: United Arab Emirates
city: Sharjah
country: United Arab Emirates
city: Dundee
country: United Kingdom
city: Hull
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: