An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)
NCT ID: NCT01344889
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4459 participants
OBSERVATIONAL
2009-10-31
2013-06-30
Brief Summary
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Major organ transplantation
* Concomitant therapy with telbivudine
* Pregnant or breast-feeding females
* Male partners of pregnant females
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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Elbasan, , Albania
Tirana, , Albania
Algiers, , Algeria
Bahrain, , Bahrain
Manama, , Bahrain
Antwerp, , Belgium
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Charleroi, , Belgium
Charleroi, , Belgium
Edegem, , Belgium
Genk, , Belgium
Gerrardsbergen, , Belgium
Ghent, , Belgium
Haine-Saint-Paul, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Mont-godinne, , Belgium
Namur, , Belgium
Ostend, , Belgium
Roeselare, , Belgium
Seraing, , Belgium
Sijsele, , Belgium
Verviers, , Belgium
Banja Luka, , Bosnia and Herzegovina
Bihać, , Bosnia and Herzegovina
Mostar, , Bosnia and Herzegovina
Sarajevo, , Bosnia and Herzegovina
Tuzla, , Bosnia and Herzegovina
Zenica, , Bosnia and Herzegovina
Salvador, Estado de Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Uberaba, Minas Gerais, Brazil
Nova Iguaçu, Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Botucatu, São Paulo, Brazil
Campinas, São Paulo, Brazil
Santo André, São Paulo, Brazil
Santos, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Alexandria, , Egypt
Cairo, , Egypt
Tanta, , Egypt
Alexandroupoli, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Ioannina, , Greece
Pátrai, , Greece
Piraeus, , Greece
Piraeus, , Greece
Rhodes, , Greece
Thessaloniki, , Greece
Ajka, , Hungary
Balassagyarmat, , Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Miskolc, , Hungary
Mosonmagyaróvár, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Tatabánya, , Hungary
Zalaegerszeg, , Hungary
Zalaegerszeg, , Hungary
Pune, Maharashtra, India
Hyderabad, , India
Kochi, , India
Lucknow, , India
Ludhiana, , India
Mizoram, , India
Mumbai, , India
Mumbai, , India
Noida, , India
Tehran, , Iran
Tehran, , Iran
Pescara, Abruzzo, Italy
Pescara, Abruzzo, Italy
Brindisi, Apulia, Italy
Foggia, Apulia, Italy
Galatina, Apulia, Italy
San Giovanni Rotondo, Apulia, Italy
Catanzaro, Calabria, Italy
Reggio Calabria, Calabria, Italy
Avellino, Campania, Italy
Benevento, Campania, Italy
Gragnano, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Salerno, Campania, Italy
Bologna, Emilia-Romagna, Italy
Carpi, Emilia-Romagna, Italy
Modena, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Ravenna, Emilia-Romagna, Italy
Udine, Friuli Venezia Giulia, Italy
Frosinone, Lazio, Italy
Gaeta, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Genoa, Liguria, Italy
Brescia, Lombardy, Italy
Brescia, Lombardy, Italy
Busto Arsizio, Lombardy, Italy
Como, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Treviglio, Lombardy, Italy
Campobasso, Molise, Italy
Asti, Piedmont, Italy
Biella, Piedmont, Italy
Novara, Piedmont, Italy
Omegna (VB), Piedmont, Italy
Orbassano, Piedmont, Italy
Turin, Piedmont, Italy
Turin, Piedmont, Italy
Cagliari, Sardinia, Italy
Cagliari, Sardinia, Italy
Sassari, Sardinia, Italy
Catania, Sicily, Italy
Comiso, Sicily, Italy
Messina, Sicily, Italy
Palermo, Sicily, Italy
Torrette Di Ancona, The Marches, Italy
Florence, Tuscany, Italy
Pisa, Tuscany, Italy
Perugia, Umbria, Italy
Padua, Veneto, Italy
Rovigo, Veneto, Italy
Hawali, , Kuwait
Safat, , Kuwait
Safat, , Kuwait
Baabda, , Lebanon
Beirut, , Lebanon
Beirut, , Lebanon
Beirut, , Lebanon
Saida, , Lebanon
Tripoli, , Lebanon
Casablanca, , Morocco
Casablanca, , Morocco
Rabat, , Morocco
Rabat, , Morocco
Skopje, , North Macedonia
Faisalabad, , Pakistan
Hyderābād, , Pakistan
Karachi, , Pakistan
Lahore, , Pakistan
Rawalpindi, , Pakistan
Bialystok, , Poland
Bydgoszcz, , Poland
Bytom, , Poland
Chorzów, , Poland
Cieszyn, , Poland
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Puławy, , Poland
Racibórz, , Poland
Tychy, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wałbrzych, , Poland
Wroclaw, , Poland
Łańcut, , Poland
Almada, , Portugal
Amadora, , Portugal
Aveiro, , Portugal
Beja, , Portugal
Beja, , Portugal
Coimbra, , Portugal
Faro, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Porto, , Portugal
Santarém, , Portugal
Vila Real, , Portugal
Doha, , Qatar
Brasov, , Romania
Brasov, , Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Cluj-Napoca, , Romania
Constanța, , Romania
Craiova, , Romania
Iași, , Romania
Iași, , Romania
Timișoara, , Romania
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Košice, , Slovakia
Martin, , Slovakia
Prešov, , Slovakia
Trenčín, , Slovakia
Buchun, , South Korea
Busan, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Abu Dhabi, , United Arab Emirates
Dubai, , United Arab Emirates
Countries
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References
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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.
Other Identifiers
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MV22255
Identifier Type: -
Identifier Source: org_study_id