An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
NCT ID: NCT01447446
Last Updated: 2017-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
4442 participants
OBSERVATIONAL
2011-09-30
2015-07-31
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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Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with chronic hepatitis C (CHC) receiving dual therapy (pegylated interferon alfa-2a \[peg-IFN Alfa-2a\] along with ribavirin according to standard of care and in line with local labeling) were followed up for the duration of their treatment and for up to 24 weeks after therapy.
Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b \[peg-IFN Alfa-2b\] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Boceprevir
Boceprevir according to standard of care and in line with local labeling.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Boceprevir
Boceprevir according to standard of care and in line with local labeling.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Telaprevir
Telaprevir according to standard of care and in line with local labeling.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Telaprevir
Telaprevir according to standard of care and in line with local labeling.
Interventions
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Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Boceprevir
Boceprevir according to standard of care and in line with local labeling.
Telaprevir
Telaprevir according to standard of care and in line with local labeling.
Eligibility Criteria
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Inclusion Criteria
* 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
* Treatment started \>4 weeks before entering study
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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Antwerp, , Belgium
Antwerp, , Belgium
Bouge, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Gilly (Charleroi), , Belgium
Hasselt, , Belgium
Heusy, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Mons, , Belgium
Montignies-sur-Sambre, , Belgium
Namur, , Belgium
Ostend, , Belgium
Roeselare, , Belgium
Verviers, , Belgium
Alexandria, , Egypt
Alexandria, , Egypt
Cairo, , Egypt
Cairo, , Egypt
Giza, , Egypt
Tanta, , Egypt
Kohtla-Järve, , Estonia
Pärnu, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Aix-en-Provence, , France
Amiens, , France
Argenteuil, , France
Avignon, , France
Besançon, , France
Besançon, , France
Béziers, , France
Boulogne-Billancourt, , France
Bourgoin, , France
Caen, , France
Chambray-lès-Tours, , France
Clichy, , France
Creil, , France
Créteil, , France
Épinay-sur-Seine, , France
Évry, , France
Freyming-Merlebach, , France
Gonesse, , France
Grasse, , France
Hyères, , France
La Tronche, , France
Lagny-sur-Marne, , France
Lille, , France
Limoges, , France
Lomme, , France
Lyon, , France
Mantes-la-Jolie, , France
Marseille, , France
Meaux, , France
Montpellier, , France
Montpellier, , France
Nice, , France
Nîmes, , France
Orange, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pau, , France
Perpignan, , France
Pessac, , France
Reims, , France
Rennes, , France
Rouen, , France
Saint-Laurent-du-Var, , France
Saint-Nazaire, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Suresnes, , France
Toulon, , France
Toulouse, , France
Tourcoing, , France
Vandœuvre-lès-Nancy, , France
Vannes, , France
Villejuif, , France
Villeneuve Maguelone, , France
Villeneuve-Saint-Georges, , France
Aachen, , Germany
Berlin, , Germany
Berlin, , Germany
Burghausen, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Erlangen, , Germany
Essen, , Germany
Kassel, , Germany
Lübeck, , Germany
Magdeburg, , Germany
Mannheim, , Germany
Rostock, , Germany
Rottenburg, , Germany
Tübingen, , Germany
Alexandroupoli, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Ioannina, , Greece
Larissa, , Greece
Nea Kifissia, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Ajka, , Hungary
Balassagyarmat, , Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Tatabánya, , Hungary
Zalaegerszeg, , Hungary
Zalaegerszeg, , Hungary
Dublin, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Chieti, Abruzzo, Italy
Bari, Apulia, Italy
Bisceglie, Apulia, Italy
Castellana Grotte, Apulia, Italy
San Giovanni Rotondo, Apulia, Italy
Reggio Calabria, Calabria, Italy
Avellino, Campania, Italy
Gragnano, Campania, Italy
Marcianise, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Nocera Inferiore, Campania, Italy
Nola, Campania, Italy
Bologna, Emilia-Romagna, Italy
Modena, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Piacenza, Emilia-Romagna, Italy
Udine, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Genoa, Liguria, Italy
Savona, Liguria, Italy
Busto Arsizio, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Biella, Piedmont, Italy
Cuorgnè (TO), Piedmont, Italy
Omegna (VB), Piedmont, Italy
Cagliari, Sardinia, Italy
Cagliari, Sardinia, Italy
Sassari, Sardinia, Italy
Catania, Sicily, Italy
Catania, Sicily, Italy
Messina, Sicily, Italy
Palermo, Sicily, Italy
Torrette Di Ancona, The Marches, Italy
Arezzo, Tuscany, Italy
Florence, Tuscany, Italy
Livorno, Tuscany, Italy
Padua, Veneto, Italy
Safat, , Kuwait
Baabda, , Lebanon
Beirut, , Lebanon
Beirut, , Lebanon
Beirut, , Lebanon
Nabatieh, , Lebanon
Tripoli, , Lebanon
Casablanca, , Morocco
Casablanca, , Morocco
Casablanca, , Morocco
Fes, , Morocco
Marrakesh, , Morocco
Rabat, , Morocco
Rabat, , Morocco
Skopje, , North Macedonia
Muscat, , Oman
Faisalabad, , Pakistan
Gujranwala, , Pakistan
Karachi, , Pakistan
Lahore, , Pakistan
Lahore, , Pakistan
Rawalpindi, , Pakistan
Almada, , Portugal
Amadora, , Portugal
Aveiro, , Portugal
Beja, , Portugal
Coimbra, , Portugal
Faro, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Doha, , Qatar
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Constanța, , Romania
Iași, , Romania
Iași, , Romania
Timișoara, , Romania
Holy Makkah, , Saudi Arabia
Riyadh, , Saudi Arabia
Riyadh, , Saudi Arabia
Belgrade, , Serbia
Novi Sad, , Serbia
Gävle, , Sweden
Karlstad, , Sweden
Uppsala, , Sweden
Lugano, , Switzerland
Sankt Gallen, , Switzerland
Aleppo, , Syria
Kaohsiung City, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Adana, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Hatay, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
ISTANBULt, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Mersin, , Turkey (Türkiye)
Tokat Province, , Turkey (Türkiye)
Trabzon, , Turkey (Türkiye)
Al Ain City, , United Arab Emirates
Dubai, , United Arab Emirates
Sharjah city, , United Arab Emirates
Dundee, , United Kingdom
Hull, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Countries
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Other Identifiers
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MV25599
Identifier Type: -
Identifier Source: org_study_id
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