Hepatitis C, ChronicNCT01344889
An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 260 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 4,459 participants
- Where
- 260 sitesin 25 countries
- Study dates
- Oct 2009to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with chronic hepatitis C receiving a long-acting interferon plus ribavirin
Who may be able to join
- 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
Who cannot join
- End stage renal disease
- Major organ transplantation
- Concomitant therapy with telbivudine
- Pregnant or breast-feeding females
- Male partners of pregnant females
Trial locations and contacts
260 sites in 25 countries.
260 sites in 25 countries
Italy61 sites
Study site
Asti, Piedmont, 14100
Study site
Avellino, Campania, 83100
Study site
Benevento, Campania, 82100
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Biella, Piedmont, 13900
Study site
Bologna, Emilia-Romagna, 40138
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Brescia, Lombardy, 25123
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Brescia, Lombardy, 25125
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Brindisi, Apulia, 72100
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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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Campobasso, Molise, 86100
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Carpi, Emilia-Romagna, 41012
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Catania, Sicily, 95126
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Catanzaro, Calabria, 88100
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Comiso, Sicily, 97013
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Como, Lombardy, 22100
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Florence, Tuscany, 50134
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Foggia, Apulia, 71100
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Frosinone, Lazio, 03100
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Gaeta, Lazio, 04024
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Galatina, Apulia, 73013
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Genoa, Liguria, 16132
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Gragnano, Campania, 80054
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Messina, Sicily, 98124
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Milan, Lombardy, 20121
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Milan, Lombardy, 20122
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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, 80123
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Naples, Campania, 80131
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Naples, Campania, 80136
Study site
Naples, Campania, 80138
Study site
Novara, Piedmont, 28100
Study site
Omegna (VB), Piedmont, 28887
Study site
Orbassano, Piedmont, 10043
Study site
Padova, Veneto, 35128
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Palermo, Sicily, 90127
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Parma, Emilia-Romagna, 43100
Study site
Perugia, Umbria, 06123
Study site
Pescara, Abruzzo, 65100
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Pescara, Abruzzo, 65124
Study site
Pisa, Tuscany, 56124
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Ravenna, Emilia-Romagna, 48100
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Reggio Calabria, Calabria, 89100
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Rome, Lazio, 00045
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Rome, Lazio, 00149
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Rome, Lazio, 00161
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Rome, Lazio, 00168
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Rovigo, Veneto, 45100
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Salerno, Campania, 84123
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San Giovanni Rotondo, Apulia, 71013
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Sassari, Sardinia, 07100
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Torrette Di Ancona, The Marches, 60020
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Treviglio, Lombardy, 24047
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Turin, Piedmont, 10126
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Turin, Piedmont, 10149
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Udine, Friuli Venezia Giulia, 33100
Belgium28 sites
Study site
Antwerp, 2018
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Antwerp, 2060
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Bruges, 8000
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Brussels, 1000
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Brussels, 1020
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Brussels, 1070
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Brussels, 1090
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Brussels, 1180
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Brussels, 1190
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Brussels, 1200
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Charleroi, 6000
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Charleroi, B6000
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Edegem, 2650
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Genk, 3600
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Gerrardsbergen, 9500
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Ghent, 9000
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Haine-Saint-Paul, 7100
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Hasselt, 3500
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Kortrijk, 8500
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Leuven, 3000
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Liège, 4000
Study site
Mont-godinne, 5530
Study site
Namur, 5000
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Ostend, 8400
Study site
Roeselare, 8800
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Seraing, 4100
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Sijsele, 8340
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Verviers, 4800
Hungary27 sites
Study site
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, H-1125
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Debrecen, 4032
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Debrecen, H-4031
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Győr, 9024
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Gyula, 5700
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Kaposvár, 7400
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Kecskemét, 6000
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Miskolc, 3529
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Miskolc, H-3501
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Mosonmagyaróvár, 9200
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Nyíregyháza, 4400
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Pécs, 7623
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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
Study site
Zalaegerszeg, 8900
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Zalaegerszeg, 8901
Poland18 sites
Study site
Bialystok, 15-540
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Bydgoszcz, 85-030
Study site
Bytom, 41-902
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Chorzów, 41-500
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Cieszyn, 43-400
Study site
Gdansk, 80-214
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Katowice, 40-752
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Krakow, 30-901
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Krakow, 31-202
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Łańcut, 37-100
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Lodz, 91-347
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Puławy, 24-100
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Racibórz, 47-400
Study site
Tychy, 43-100
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Wałbrzych, 58-300
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Warsaw, 01-201
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Warsaw, 02-507
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Wroclaw, 51-124
Greece16 sites
Study site
Alexandroupoli, 68100
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Athens, 10552
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Athens, 10676
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Athens, 115 27
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Athens, 11521
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Athens, 11522
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Athens, 11526
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Athens, 11527
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Athens, 14233
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Athens, 15121
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Ioannina, 455 00
Study site
Pátrai, 265 04
Study site
Piraeus, 18454
Study site
Piraeus, 18536
Study site
Rhodes, 85100
Study site
Thessaloniki, 546 42
Romania16 sites
Study site
Brasov, 500007
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Brasov, 500174
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Brasov, 500326
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Bucharest, 005098
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Bucharest, 010825
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Bucharest, 020475
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Bucharest, 021105
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Bucharest, 022328
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Bucharest, 030303
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Cluj-Napoca, 400015
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Cluj-Napoca, 400162
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Constanța, 900900
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Craiova, 200515
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Iași, 700111
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Iași, 700116
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Timișoara, 293406
Brazil14 sites
Study site
Belo Horizonte, Minas Gerais, 31270-901
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Botucatu, São Paulo, 18600-400
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Campinas, São Paulo, 13026-210
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Nova Iguaçu, Rio de Janeiro, 26030-380
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Rio de Janeiro, Rio de Janeiro, 20020-022
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Rio de Janeiro, Rio de Janeiro, 20270-004
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Salvador, Estado de Bahia, 41110-170
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Santo André, São Paulo, 09060-650
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Santos, São Paulo, 11015470
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São José do Rio Preto, São Paulo, 15090-000
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São Paulo, São Paulo, 04040-002
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São Paulo, São Paulo, 04040-003
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Sorocaba, São Paulo, 18047-600
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Uberaba, Minas Gerais, 38025-180
Portugal14 sites
Study site
Almada, 2805-267
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Amadora, 2700-020
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Aveiro, 3810-096
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Beja, 7800-309
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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, 1069-639
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Lisbon, 1349-019
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Lisbon, 1649-035
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Porto, 4202-451
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Porto, 4369-004
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Santarém, 2005-177
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Vila Real, 5000-508
India9 sites
Study site
Hyderabad, 500082
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Kochi, 682017
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Lucknow, 226010
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Ludhiana, 141 001
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Mizoram, 0
Study site
Mumbai, 400025
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Mumbai, 400053
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Noida, 201 301
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Pune, Maharashtra, 411001
Slovakia9 sites
Study site
Banská Bystrica, 975 17
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Bratislava, 811 07
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Bratislava, 833 03
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Bratislava, 833 05
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Košice, 040 01
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Košice, 04001
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Martin, 036 59
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Prešov, 080 01
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Trenčín, 911 71
Bosnia and Herzegovina6 sites
Study site
Banja Luka, 78000
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Bihać, 77000
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Mostar, 88000
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Sarajevo, 71000
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Tuzla, 75000
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Zenica, 72000
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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Saida
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Tripoli, 371 Tripoli
South Korea6 sites
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Buchun, 420-021
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Busan, 602-715
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Seoul, 03080
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Seoul, 120-752
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Seoul, 135-710
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Suwon, 442-723
Pakistan5 sites
Study site
Faisalabad
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Hyderābād, 71000
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Karachi
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Lahore
Study site
Rawalpindi
Morocco4 sites
Study site
Casablanca, 20000
Study site
Casablanca, 20100
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Rabat, 504
Study site
Rabat, 62000
Serbia4 sites
Study site
Belgrade, 11000
Study site
Kragujevac, 34000
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Niš, 18000
Study site
Novi Sad, 21000
Kuwait3 sites
Study site
Hawalli, 32052
Study site
Safat, 4077
Study site
Safat, 4710
United Arab Emirates2 sites
Study site
Abu Dhabi, 51900
Study site
Dubai, 4545
About this study
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
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.
- Conditions
- Hepatitis C, Chronic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin
Measured: 4 years
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)
Measured: 4 years
Secondary outcomes (4)
Correlation of on-treatment factors and dose reduction/treatment discontinuation
Measured: 4 years
Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR
Measured: 4 years
Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients
Measured: 4 years
Safety: Incidence of adverse events
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 4,459 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
- NCT01344889
- Sponsor's protocol ID
- MV22255
- Status last verified
- Nov 2016
- First submitted
- 27 Apr 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
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.
PubMed 27018988
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01344889
- Acronym / sponsor ID
- MV22255
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,459 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C receiving a long-acting interferon plus ribavirin
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- End stage renal disease
- Major organ transplantation
- Concomitant therapy with telbivudine
- Pregnant or breast-feeding females
- Male partners of pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin
Time frame: 4 years
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)
Time frame: 4 years
4 secondary outcomes
Correlation of on-treatment factors and dose reduction/treatment discontinuation
Time frame: 4 years
Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR
Time frame: 4 years
Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients
Time frame: 4 years
Safety: Incidence of adverse events
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 27018988Foster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
260 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 260 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 260 sites in Italy, Belgium, Hungary, Poland, Greece and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.