Hepatitis C, ChronicNCT01447446
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 271 sites in 27 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Peg-IFN Alfa-2a, Peg-IFN Alfa-2b and Ribavirin
- How many people
- 4,442 participants
- Where
- 271 sitesin 27 countries
- Study dates
- Sep 2011to Jul 2015
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Contraindications according to SPC/local labeling
- Treatment started >4 weeks before entering study
Trial locations and contacts
271 sites in 27 countries.
271 sites in 27 countries
France59 sites
Study site
Aix-en-Provence, 13616
Study site
Amiens, 80054
Study site
Argenteuil, 95107
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Avignon, 84902
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Besançon, 25000
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Besançon, 25030
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Béziers, 34500
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Boulogne-Billancourt, 92104
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Bourgoin, 38300
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Caen, 14033
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Chambray-lès-Tours, 37171
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Clichy, 92118
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Creil, 60109
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Créteil, 94010
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Épinay-sur-Seine, 93806
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Évry, 91014
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Freyming-Merlebach, 57804
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Gonesse, 95503
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Grasse, 06130
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Hyères, 83407
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La Tronche, 38700
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Lagny-sur-Marne, 77405
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Lille, 59037
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Limoges, 87042
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Lomme, 59462
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Lyon, 69009
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Mantes-la-Jolie, 78200
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Marseille, 13285
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Meaux, 77104
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Montpellier, 34070
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Montpellier, 34295
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Nice, 06202
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Nîmes, 30029
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Orange, 84100
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Orléans, 45100
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Paris, 75571
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Paris, 75651
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Paris, 75679
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Paris, 75908
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Paris, 75970
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Pau, 64046
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Perpignan, 66046
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Pessac, 33604
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Reims, 51092
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Rennes, 35033
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Rouen, 76031
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Saint-Laurent-du-Var, 06700
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Saint-Nazaire, 44606
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Saint-Priest-en-Jarez, 42277
Study site
Strasbourg, 67091
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Suresnes, 92151
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Toulon, 83000
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Toulouse, 31059
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Tourcoing, 59208
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Vandœuvre-lès-Nancy, 54511
Study site
Vannes, 56017
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Villejuif, 94804
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Villeneuve Maguelone, 34751
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Villeneuve-Saint-Georges, 94195
Italy48 sites
Study site
Arezzo, Tuscany, 52100
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Avellino, Campania, 83100
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Bari, Apulia, 70124
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Biella, Piedmont, 13900
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Bisceglie, Apulia, 70052
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Bologna, Emilia-Romagna, 40138
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Busto Arsizio, Lombardy, 21052
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Cagliari, Sardinia, 09042
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Cagliari, Sardinia, 09100
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Castellana Grotte, Apulia, 70013
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Catania, Sicily, 95100
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Catania, Sicily, 95126
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Chieti, Abruzzo, 66013
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Cuorgnè (TO), Piedmont, 10082
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Florence, Tuscany, 50134
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Genoa, Liguria, 16132
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Gragnano, Campania, 80054
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Livorno, Tuscany, 57124
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Marcianise, Campania, 81025
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Messina, Sicily, 98124
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Milan, Lombardy, 20122
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Milan, Lombardy, 20123
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Milan, Lombardy, 20132
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Milan, Lombardy, 20142
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Milan, Lombardy, 20157
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Milan, Lombardy, 20162
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Modena, Emilia-Romagna, 41100
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Naples, Campania, 80131
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Naples, Campania, 80136
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Naples, Campania, 80138
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Nocera Inferiore, Campania, 84014
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Nola, Campania, 80035
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Omegna (VB), Piedmont, 28887
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Padova, Veneto, 35128
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Palermo, Sicily, 90127
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Parma, Emilia-Romagna, 43126
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Piacenza, Emilia-Romagna, 29121
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Reggio Calabria, Calabria, 89100
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Rome, Lazio, 00149
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Rome, Lazio, 00152
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Rome, Lazio, 00161
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Rome, Lazio, 00165
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Rome, Lazio, 00189
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San Giovanni Rotondo, Apulia, 71013
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Sassari, Sardinia, 07100
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Savona, Liguria, 17100
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Torrette Di Ancona, The Marches, 60020
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Udine, Friuli Venezia Giulia, 33100
Hungary25 sites
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Ajka, H-8400
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Balassagyarmat, 2660
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Békéscsaba, 5600
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Budapest, 1067
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Budapest, 1083
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Budapest, 1088
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Budapest, 1097
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Budapest, 1126
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Budapest, H-1125
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Debrecen, 4032
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Debrecen, H-4031
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Gyula, 5700
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Kaposvár, 7400
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Kecskemét, 6000
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Miskolc, H-3501
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Nyíregyháza, 4400
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Pécs, 7624
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Sopron, 9400
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Szeged, 6720
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Székesfehérvár, 8000
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Szolnok, 5000
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Szombathely, 9700
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Tatabánya, 2800
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Zalaegerszeg, 8900
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Zalaegerszeg, 8901
Belgium23 sites
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Antwerp, 2018
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Antwerp, 2060
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Bouge, 5004
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Brussels, 1000
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Brussels, 1020
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Brussels, 1070
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Brussels, 1180
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Brussels, 1190
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Brussels, 1200
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Edegem, 2650
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Ghent, 9000
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Gilly (Charleroi), 6000
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Hasselt, 3500
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Heusy, 4802
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Kortrijk, 8500
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Leuven, 3000
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Liège, 4000
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Mons, 7000
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Montignies-sur-Sambre, 6061
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Namur, 5000
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Ostend, 8400
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Roeselare, 8800
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Verviers, 4800
Germany15 sites
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Aachen, 52074
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Berlin, 10243
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Berlin, 10777
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Burghausen, 84489
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Cologne, 50937
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Düsseldorf, 40237
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Erlangen, 91054
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Essen, 45122
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Kassel, 34117
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Lübeck, 23562
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Magdeburg, 39120
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Mannheim, 68167
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Rostock, 18057
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Rottenburg, 72108
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Tübingen, 72076
Turkey (Türkiye)13 sites
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Adana, 01100
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Ankara, 06100
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Ankara, 06290
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Ankara, 06800
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Ankara
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Hatay, 31040
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Istanbul, 34390
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ISTANBULt
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Izmir, 35100
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Kayseri, 38039
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Mersin, 33169
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Tokat Province, 60250
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Trabzon, 61080
Greece9 sites
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Alexandroupoli, 68100
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Athens, 115 27
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Athens, 11522
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Athens, 11527
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Ioannina, 455 00
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Larissa, 41 110
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Nea Kifissia, 14564
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Pátrai, 265 04
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Thessaloniki, 546 42
Portugal9 sites
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Almada, 2805-267
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Amadora, 2700-020
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Aveiro, 3810-096
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Beja, 7801-849
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Coimbra, 3041-801
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Faro, 8000-386
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Lisbon, 1349-019
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Lisbon, 1649-035
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Porto, 4099-001
Morocco7 sites
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Casablanca, 20000
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Casablanca, 20100
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Casablanca
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Fes
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Marrakesh
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Rabat, 504
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Rabat, 62000
Romania7 sites
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Bucharest, 021105
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Bucharest, 022328
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Cluj-Napoca, 400162
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Constanța
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Iași, 700554
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Iași, 700620
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Timișoara, 300167
Egypt6 sites
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Alexandria, 0
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Alexandria
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Cairo, 0
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Cairo
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Giza
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Tanta
Lebanon6 sites
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Baabda, 50
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Beirut, 11-236
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Beirut, 99999
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Beirut
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Nabatieh
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Tripoli, 371 Tripoli
Pakistan6 sites
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Faisalabad
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Gujranwala
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Karachi
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Lahore, 20021
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Lahore
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Rawalpindi
Taiwan6 sites
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Kaohsiung City, 00833
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Kaohsiung City, 807
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Taichung, 40447
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Taipei, 100
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Taipei, 112
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Taoyuan, 333
United Kingdom6 sites
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Dundee, DD1 9SY
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Hull, HU3 2JZ
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London, E1 1BB
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London, W2 1NY
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Manchester, M8 5RB
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Nottingham, NG7 2UH
Estonia5 sites
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Kohtla-Järve, 31025
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Pärnu, 80010
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Tallinn, 10138
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Tallinn, 10617
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Tartu, 51014
Saudi Arabia3 sites
Study site
Holy Makkah, 21583-Makkah P.O.Box-53356
Study site
Riyadh, 11159
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Riyadh, 11211
Sweden3 sites
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Gävle, 80187
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Karlstad, 65185
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Uppsala, 75185
United Arab Emirates3 sites
Study site
Al Ain City, P.O.Box 1006
Study site
Dubai, 4545
Study site
Sharjah city, P.O.Box: 5735 - Sharjah, UAE
About this study
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
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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peg-IFN Alfa-2a, Peg-IFN Alfa-2b, Ribavirin, Boceprevir, Telaprevir
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-IFN Alfa-2aDrug
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Peg-IFN Alfa-2bDrug
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
RibavirinDrug
Ribavirin according to standard of care and in line with local labeling.
BoceprevirDrug
Boceprevir according to standard of care and in line with local labeling.
TelaprevirDrug
Telaprevir according to standard of care and in line with local labeling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Peg-IFN Alfa-2a; Drug: Ribavirin | |
| 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. Receives: Drug: Peg-IFN Alfa-2b; Drug: Ribavirin | |
| 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. Receives: Drug: Peg-IFN Alfa-2a; Drug: Ribavirin; Drug: Boceprevir | |
| 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. Receives: Drug: Peg-IFN Alfa-2b; Drug: Ribavirin; Drug: Boceprevir | |
| 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. Receives: Drug: Peg-IFN Alfa-2a; Drug: Ribavirin; Drug: Telaprevir | |
| 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. Receives: Drug: Peg-IFN Alfa-2b; Drug: Ribavirin; Drug: Telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.
Measured: 24 weeks after end of treatment (up to 118 weeks)
Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.
Measured: 12 weeks after end of treatment (up to 118 weeks)
Secondary outcomes (12)
Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.
Measured: Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
Virological Relapse After End of Treatment
Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).
Measured: Up to 24 weeks after EOT (up to 118 weeks)
Virological Breakthrough
Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
Measured: Up to EOT (up to 118 weeks)
Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
Measured: Up to first 12 weeks of treatment
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
Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
Measured: Up to 12 weeks
Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
Measured: Up to 98 weeks
Duration of Overall Treatment
Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
Measured: Up to 118 weeks
Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
Measured: Up to 118 weeks
Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
Participants who prolonged the treatment period from 72 weeks were not reported.
Measured: Up to 72 weeks of treatment
Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
Measured: Up to 72 weeks of treatment
Percentage of Participants With Concomitant Medical Condition at Baseline
Measured: Baseline
Percentage of Participants With Adverse Events (AE)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Measured: Up to 118 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447446
- Sponsor's protocol ID
- MV25599
- Status last verified
- Dec 2016
- First submitted
- 4 Oct 2011
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov