An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 4, 2011
Last updated: November 2, 2015
Last verified: November 2015
This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of peginterferon alfa (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in patients with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from patients receiving treatment according to current Summary of Product Characteristics and local labeling for the duration of their treatment and a 24-week follow-up.

Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks past completion of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response (in correlation with on-treatment factors) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Duration of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Percentage of patients treated according to label / Summary of Product Characteristics (SPC) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Treatment discontinuation (time, reasons) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Sustained virological response in correlation with dose reductions/treatment interruptions [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Treatment (drugs, regimen) in relation to medical history/concomitant medical conditions [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of viral rebound on DAA based triple therapy [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 4449
Study Start Date: September 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic hepatitis C patients (naïve or treatment experienced and HIV HCV co-infected) receiving combination therapy with pegylated interferons plus ribavirin or treatment regimens containing direct-acting antivirals

Inclusion Criteria:

  • Adult (according to local legislation) patients
  • Chronic hepatitis C (HCV)
  • Naïve or treatment experienced and HIV HCV co-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:

  • Contraindications according to SPC/local labeling
  • Treatment started >4 weeks before entering study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01447446

  Hide Study Locations
Antwerpen, Belgium, 2018
Antwerpen, Belgium, 2060
Bouge, Belgium, 5004
Brussels, Belgium, 1000
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1180
Bruxelles, Belgium, 1190
Bruxelles, Belgium, 1200
Edegem, Belgium, 2650
Gent, Belgium, 9000
Gilly (Charleroi), Belgium, 6060
Hasselt, Belgium, 3500
Heusy, Belgium, 4802
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Liège, Belgium, 4000
Mons, Belgium, 7000
Montignies sur Sambre, Belgium, 6061
Namur, Belgium, 5000
Oostende, Belgium, 8400
Roeselare, Belgium, 8800
Verviers, Belgium, 4800
Alexandria, Egypt, 0
Alexandria, Egypt
Cairo, Egypt
Cairo, Egypt, 0
Giza, Egypt
Tanta, Egypt
Kohtla-Järve, Estonia, 31025
Pärnu, Estonia, 80010
Tallinn, Estonia, 10138
Tallinn, Estonia, 10617
Tartu, Estonia, 51014
Aix En Provence, France, 13616
Amiens, France, 80054
Argenteuil, France, 95107
Avignon, France, 84902
Besancon, France, 25000
Besancon, France, 25030
Beziers, France, 34500
Boulogne Billancourt, France, 92104
Bourgoin Jallieu, France, 38300
Caen, France, 14033
Chambray Les Tours, France, 37171
Clichy, France, 92118
Creil, France, 60109
Creteil, France, 94010
Epinay-Sur-Seine, France, 93806
Evry, France, 91014
Freyming Merlebach, France, 57804
Gonesse, France, 95503
Grasse, France, 06130
Hyeres, France, 83407
La Tronche, France, 38700
Lagny Sur Marne, France, 77405
Lille, France, 59037
Limoges, France, 87042
Lomme, France, 59462
Lyon, France, 69009
Mantes La Jolie, France, 78200
Marseille, France, 13285
Meaux, France, 77104
Montpellier, France, 34070
Montpellier, France, 34295
Nice, France, 06202
Nimes, France, 30029
Orange, France, 84100
Orleans, France, 45100
Paris, France, 75970
Paris, France, 75651
Paris, France, 75679
Paris, France, 75908
Paris, France, 75571
Pau, France, 64046
Perpignan, France, 66046
Pessac, France, 33604
Reims, France, 51092
Rennes, France, 35033
Rouen, France, 76031
Saint Nazaire, France, 44606
St Laurent Du Var, France, 06700
St Priest En Jarez, France, 42277
Strasbourg, France, 67091
Suresnes, France, 92151
Toulon, France, 83000
Toulouse, France, 31059
Tourcoing, France, 59208
Vandoeuvre-les-nancy, France, 54511
Vannes, France, 56017
Villejuif, France, 94804
Villeneuve Maguelone, France, 34751
Villeneuve St Georges, France, 94195
Aachen, Germany, 52074
Berlin, Germany, 10243
Berlin, Germany, 10777
Burghausen, Germany, 84489
Düsseldorf, Germany, 40237
Erlangen, Germany, 91054
Essen, Germany, 45122
Kassel, Germany, 34117
Köln, Germany, 50937
Lübeck, Germany, 23562
Magdeburg, Germany, 39120
Mannheim, Germany, 68167
Rostock, Germany, 18057
Rottenburg, Germany, 72108
Tübingen, Germany, 72076
Alexandroupolis, Greece, 68100
Athens, Greece, 115 27
Athens, Greece, 11522
Athens, Greece, 11527
Ioannina, Greece, 455 00
Larissa, Greece, 41 110
Nea Kifissia, Greece, 14564
Patra, Greece, 265 04
Thessaloniki, Greece, 546 42
Ajka, Hungary, H-8400
Balassagyarmat, Hungary, 2660
Bekescsaba, Hungary, 5600
Budapest, Hungary, H-1125
Budapest, Hungary, 1067
Budapest, Hungary, 1088
Budapest, Hungary, 1097
Budapest, Hungary, 1126
Budapest, Hungary, 1083
Debrecen, Hungary, 4032
Debrecen, Hungary, H-4031
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Kecskemet, Hungary, 6000
Miskolc, Hungary, H-3501
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7624
Sopron, Hungary, 9400
Szeged, Hungary, 6720
Szekesfehervar, Hungary, 8000
Szolnok, Hungary, 5000
Szombathely, Hungary, 9700
Székesfehérvár, Hungary, 8000
Tatabánya, Hungary, 2800
Zalaegerszeg, Hungary, 8900
Zalaegerszeg, Hungary, 8901
Dublin, Ireland, 4
Dublin, Ireland, 8
Dublin, Ireland, 9
Chieti, Abruzzo, Italy, 66013
Reggio Calabria, Calabria, Italy, 89100
Avellino, Campania, Italy, 83100
Gragnano, Campania, Italy, 80054
Marcianise, Campania, Italy, 81025
Napoli, Campania, Italy, 80138
Napoli, Campania, Italy, 80131
Napoli, Campania, Italy, 80136
Nocera Inferiore, Campania, Italy, 84014
Nola, Campania, Italy, 80035
Bologna, Emilia-Romagna, Italy, 40138
Modena, Emilia-Romagna, Italy, 41100
Parma, Emilia-Romagna, Italy, 43126
Piacenza, Emilia-Romagna, Italy, 29121
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00149
Roma, Lazio, Italy, 00152
Roma, Lazio, Italy, 00161
Roma, Lazio, Italy, 00165
Roma, Lazio, Italy, 00189
Genova, Liguria, Italy, 16132
Savona, Liguria, Italy, 17100
Busto Arsizio, Lombardia, Italy, 21052
Milano, Lombardia, Italy, 20157
Milano, Lombardia, Italy, 20123
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20142
Milano, Lombardia, Italy, 20122
Milano, Lombardia, Italy, 20162
Torrette Di Ancona, Marche, Italy, 60020
Biella, Piemonte, Italy, 13900
Cuorgnè (TO), Piemonte, Italy, 10082
Omegna (VB), Piemonte, Italy, 28887
Bari, Puglia, Italy, 70124
Bisceglie, Puglia, Italy, 70052
Castellana Grotte, Puglia, Italy, 70013
San Giovanni Rotondo, Puglia, Italy, 71013
Cagliari, Sardegna, Italy, 09042
Cagliari, Sardegna, Italy, 09100
Sassari, Sardegna, Italy, 07100
Catania, Sicilia, Italy, 95100
Catania, Sicilia, Italy, 95126
Messina, Sicilia, Italy, 98124
Palermo, Sicilia, Italy, 90127
Arezzo, Toscana, Italy, 52100
Firenze, Toscana, Italy, 50134
Livorno, Toscana, Italy, 57124
Padova, Veneto, Italy, 35128
Safat, Kuwait, 13041
Baabda, Lebanon, 50
Beirut, Lebanon, 99999
Beirut, Lebanon
Beirut, Lebanon, 11-236
Nabatieh, Lebanon
Tripoli, Lebanon, 371 Tripoli
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Casablanca, Morocco
Casablanca, Morocco, 20000
Casablanca, Morocco, 20100
Fes, Morocco
Marrakech, Morocco
Rabat, Morocco, 504
Rabat, Morocco, 62000
Muscat, Oman, P.O Box 35
Faisalabad, Pakistan
Gujranwala, Pakistan
Karachi, Pakistan
Lahore, Pakistan
Lahore, Pakistan, 20021
Rawalpindi, Pakistan
Almada, Portugal, 2805-267
Amadora, Portugal, 2700-020
Aveiro, Portugal, 3810-096
Beja, Portugal, 7801-849
Coimbra, Portugal, 3041-801
Faro, Portugal, 8000-386
Lisboa, Portugal, 1349-019
Lisboa, Portugal, 1649-035
Porto, Portugal, 4099-001
Doha, Qatar, P.O.Box 3051
Bucharest, Romania, 021105
Bucharest, Romania, 022328
Cluj-napoca, Romania, 400162
Constanta, Romania
Iasi, Romania, 700554
Iasi, Romania, 700620
Timisoara, Romania, 300167
Saudi Arabia
Holy Makkah, Saudi Arabia, 21583-Makkah P.O.Box-53356
Riyadh, Saudi Arabia, 11159
Riyadh, Saudi Arabia, 11211
Belgrade, Serbia, 11000
Novi Sad, Serbia, 21000
Gävle, Sweden, 80187
Karlstad, Sweden, 65185
Uppsala, Sweden, 75185
Lugano, Switzerland, 6900
St. Gallen, Switzerland, 9007
Syrian Arab Republic
Aleppo, Syrian Arab Republic, 6448
Kaohsiung, Taiwan, 00833
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 40447
Taipei, Taiwan, 112
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Adana, Turkey, 01100
Ankara, Turkey
Ankara, Turkey, 06100
Ankara, Turkey, 06290
Ankara, Turkey, 06800
Hatay, Turkey, 31040
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
Kayseri, Turkey, 38039
Mersin, Turkey, 33169
Tokat, Turkey, 60250
Trabzon, Turkey, 61080
United Arab Emirates
Al Ain, United Arab Emirates, P.O.Box 1006
Dubai, United Arab Emirates, 4545
Sharjah, United Arab Emirates, P.O.Box: 5735 - Sharjah, UAE
United Kingdom
Dundee, United Kingdom, DD1 9SY
Hull, United Kingdom, HU3 2JZ
London, United Kingdom, W2 1NY
London, United Kingdom, E1 1BB
Manchester, United Kingdom, M8 5RB
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01447446     History of Changes
Other Study ID Numbers: MV25599
Study First Received: October 4, 2011
Last Updated: November 2, 2015
Health Authority: Syria: Ministry of Health

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 27, 2015