Clinical trial NCT01344889: An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)
Official title: Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected With Chronic Hepatitis C Receiving a Long Acting Interferon Plus Ribavirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 4459
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 with chronic hepatitis C receiving a long-acting interferon plus ribavirin

Brief summary: This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.


Eligibility criteria: Inclusion Criteria:

* Adult patients (according to local legislation)
* Chronic hepatitis C
* Treatment with long-acting interferon plus ribavirin
* Quantifiable HCV RNA before initiation of treatment
* No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label

Exclusion Criteria:

* End stage renal disease
* Major organ transplantation
* Concomitant therapy with telbivudine
* Pregnant or breast-feeding females
* Male partners of pregnant females

Primary outcomes:
measure: Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin
timeFrame: 4 years
measure: Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment)
timeFrame: 4 years
Secondary outcomes:
measure: Correlation of on-treatment factors and dose reduction/treatment discontinuation
timeFrame: 4 years
measure: Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR
timeFrame: 4 years
measure: Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients
timeFrame: 4 years
measure: Safety: Incidence of adverse events
timeFrame: 4 years
Other outcomes:
Locations:
city: Elbasan
country: Albania
city: Tirana
country: Albania
city: Algiers
country: Algeria
city: Bahrain
country: Bahrain
city: Manama
country: Bahrain
city: Antwerpen
country: Belgium
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Brussel
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: Charleroi
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Gerrardsbergen
country: Belgium
city: Haine-Saint-Paul
country: Belgium
city: Hasselt
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Mont-godinne
country: Belgium
city: Namur
country: Belgium
city: Oostende
country: Belgium
city: Roeselare
country: Belgium
city: Seraing
country: Belgium
city: Sijsele
country: Belgium
city: Verviers
country: Belgium
city: Banja Luka
country: Bosnia and Herzegovina
city: Bihac
country: Bosnia and Herzegovina
city: Mostar
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Tuzla
country: Bosnia and Herzegovina
city: Zenica
country: Bosnia and Herzegovina
city: Salvador
country: Brazil
state: BA
city: Belo Horizonte
country: Brazil
state: MG
city: Uberaba
country: Brazil
state: MG
city: Nova Iguacu
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Botucatu
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Santos
country: Brazil
state: SP
city: Sao Jose do Rio Preto
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
city: Alexandria
country: Egypt
city: Cairo
country: Egypt
city: Tanta
country: Egypt
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Patra
country: Greece
city: Piraeus
country: Greece
city: Piraeus
country: Greece
city: Rhodes
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: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvár
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Miskolc
country: Hungary
city: Mosonmagyaróvár
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Sopron
country: Hungary
city: Szeged
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: Pune
country: India
state: Maharashtra
city: Cochin
country: India
city: Hyderabad
country: India
city: Lucknow
country: India
city: Ludhiana
country: India
city: Mizoram
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: Noida
country: India
city: Tehran
country: Iran, Islamic Republic of
city: Tehran
country: Iran, Islamic Republic of
city: Pescara
country: Italy
state: Abruzzo
city: Pescara
country: Italy
state: Abruzzo
city: Catanzaro
country: Italy
state: Calabria
city: Reggio Calabria
country: Italy
state: Calabria
city: Avellino
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: Salerno
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Carpi
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Ravenna
country: Italy
state: Emilia-Romagna
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Frosinone
country: Italy
state: Lazio
city: Gaeta
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: Brescia
country: Italy
state: Lombardia
city: Brescia
country: Italy
state: Lombardia
city: Busto Arsizio
country: Italy
state: Lombardia
city: Como
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: Treviglio
country: Italy
state: Lombardia
city: Torrette Di Ancona
country: Italy
state: Marche
city: Campobasso
country: Italy
state: Molise
city: Asti
country: Italy
state: Piemonte
city: Biella
country: Italy
state: Piemonte
city: Novara
country: Italy
state: Piemonte
city: Omegna (VB)
country: Italy
state: Piemonte
city: Orbassano
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Brindisi
country: Italy
state: Puglia
city: Foggia
country: Italy
state: Puglia
city: Galatina
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: Comiso
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Padova
country: Italy
state: Veneto
city: Rovigo
country: Italy
state: Veneto
city: Buchun
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Hawali
country: Kuwait
city: Safat
country: Kuwait
city: Safat
country: Kuwait
city: Baabda
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Saida
country: Lebanon
city: Tripoli
country: Lebanon
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Rabat
country: Morocco
city: Rabat
country: Morocco
city: Faisalabad
country: Pakistan
city: Hyderabad
country: Pakistan
city: Karachi
country: Pakistan
city: Lahore
country: Pakistan
city: Rawalpindi
country: Pakistan
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Chorzow
country: Poland
city: Cieszyn
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lancut
country: Poland
city: Lodz
country: Poland
city: Pulawy
country: Poland
city: Raciborz
country: Poland
city: Tychy
country: Poland
city: Walbrzych
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Łodz
country: Poland
city: Almada
country: Portugal
city: Amadora
country: Portugal
city: Aveiro
country: Portugal
city: Beja
country: Portugal
city: Beja
country: Portugal
city: Coimbra
country: Portugal
city: Faro
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: Santarém
country: Portugal
city: Vila Real
country: Portugal
city: Doha
country: Qatar
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: Cluj Napoca
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: NIS
country: Serbia
city: Novi Sad
country: Serbia
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Kosice
country: Slovakia
city: Martin
country: Slovakia
city: Presov
country: Slovakia
city: Trencin
country: Slovakia
city: Abu Dhabi
country: United Arab Emirates
city: Dubai
country: United Arab Emirates
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Foster GR, Coppola C, Derbala M, Ferenci P, Orlandini A, Reddy KR, Tallarico L, Shiffman ML, Ahlers S, Bakalos G, Hassanein T; GUARD-C Study Group. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort. PLoS One. 2016 Mar 28;11(3):e0151703. doi: 10.1371/journal.pone.0151703. eCollection 2016.