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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447446
First received: October 4, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

This prospective, multicenter, observational cohort study will evaluate the effi cacy and safety of peginterferon alfa (e.g. Pegasys) plus ribavirin and treatmen t regimens containing direct-acting antivirals in patients with chronic hepatiti s C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Da ta will be collected from patients receiving treatment according to current Summ ary of Product Characteristics and local labeling for the duration of their trea tment and a 24-week follow-up.


Condition
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 ]

Estimated Enrollment: 4000
Study Start Date: September 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01447446

Contacts
Contact: Reference Study ID Number: MV25599 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
Belgium
Active, not recruiting
Antwerpen, Belgium, 2018
Active, not recruiting
Antwerpen, Belgium, 2060
Active, not recruiting
Bouge, Belgium, 5004
Active, not recruiting
Bruxelles, Belgium, 1070
Active, not recruiting
Bruxelles, Belgium, 1180
Active, not recruiting
Bruxelles, Belgium, 1190
Active, not recruiting
Bruxelles, Belgium, 1200
Active, not recruiting
Bruxelles, Belgium, 1020
Active, not recruiting
Bruxelles, Belgium, 1000
Active, not recruiting
Edegem, Belgium, 2650
Terminated
Gent, Belgium, 9000
Active, not recruiting
Gent, Belgium, 9000
Active, not recruiting
Gilly, Belgium, 6060
Active, not recruiting
Hasselt, Belgium, 3500
Active, not recruiting
Heusy, Belgium, 4802
Active, not recruiting
Kortrijk, Belgium, 8500
Active, not recruiting
Leuven, Belgium, 3000
Recruiting
Liege, Belgium, 4000
Active, not recruiting
Liège, Belgium, 4000
Completed
Mons, Belgium, 7000
Active, not recruiting
Mons, Belgium, 7000
Active, not recruiting
Montignies sur Sambre, Belgium, 6061
Active, not recruiting
Namur, Belgium, 5000
Active, not recruiting
Oostende, Belgium, 8400
Active, not recruiting
Roeselare, Belgium, 8800
Active, not recruiting
Verviers, Belgium, 4800
Egypt
Completed
Alexandria, Egypt, 0
Completed
Alexandria, Egypt
Active, not recruiting
Cairo, Egypt
Completed
Cairo, Egypt, 0
Completed
Cairo, Egypt
Terminated
Cairo, Egypt
Active, not recruiting
Cairo, Egypt, 0
Completed
Giza, Egypt
Active, not recruiting
Giza, Egypt
Active, not recruiting
Tanta, Egypt
Estonia
Active, not recruiting
Kohtla-Järve, Estonia, 31025
Active, not recruiting
Pärnu, Estonia, 80010
Active, not recruiting
Tallinn, Estonia, 10617
Completed
Tallinn, Estonia, 10138
Active, not recruiting
Tartu, Estonia, 51014
France
Active, not recruiting
Aix En Provence, France, 13616
Active, not recruiting
Amiens, France, 80054
Active, not recruiting
Argenteuil, France, 95107
Active, not recruiting
Avignon, France, 84902
Active, not recruiting
Besancon, France, 25030
Active, not recruiting
Besancon, France, 25000
Active, not recruiting
Beziers, France, 34500
Active, not recruiting
Boulogne Billancourt, France, 92104
Active, not recruiting
Bourgoin Jallieu, France, 38300
Active, not recruiting
Caen, France, 14033
Active, not recruiting
Chambray Les Tours, France, 37171
Active, not recruiting
Clichy, France, 92118
Active, not recruiting
Creil, France, 60109
Active, not recruiting
Creteil, France, 94010
Active, not recruiting
Epinay-Sur-Seine, France, 93806
Active, not recruiting
Evry, France, 91014
Active, not recruiting
Freyming Merlebach, France, 57804
Active, not recruiting
Gonesse, France, 95503
Active, not recruiting
Grasse, France, 06130
Active, not recruiting
Hyeres, France, 83407
Terminated
La Tronche, France, 38700
Active, not recruiting
Lagny Sur Marne, France, 77405
Active, not recruiting
Lille, France, 59037
Active, not recruiting
Limoges, France, 87042
Terminated
Lomme, France, 59462
Active, not recruiting
Lyon, France, 69009
Active, not recruiting
Mantes La Jolie, France, 78200
Active, not recruiting
Marseille, France, 13285
Active, not recruiting
Meaux, France, 77104
Active, not recruiting
Montpellier, France, 34070
Active, not recruiting
Montpellier, France, 34295
Terminated
Montpellier, France, 34295
Active, not recruiting
Nice, France, 06202
Active, not recruiting
Nimes, France, 30029
Active, not recruiting
Orange, France, 84100
Active, not recruiting
Orleans, France, 45100
Active, not recruiting
Paris, France, 75908
Active, not recruiting
Paris, France, 75571
Active, not recruiting
Paris, France, 75679
Active, not recruiting
Paris, France, 75651
Not yet recruiting
Paris, France, 75679
Terminated
Paris, France, 75970
Terminated
Paris, France, 75651
Active, not recruiting
Pau, France, 64046
Active, not recruiting
Perpignan, France, 66046
Active, not recruiting
Pessac, France, 33604
Active, not recruiting
Reims, France, 51092
Active, not recruiting
Rennes, France, 35033
Active, not recruiting
Rouen, France, 76031
Terminated
Saint Nazaire, France, 44606
Active, not recruiting
St Laurent Du Var, France, 06700
Active, not recruiting
St Priest En Jarez, France, 42277
Active, not recruiting
Strasbourg, France, 67091
Active, not recruiting
Suresnes, France, 92151
Active, not recruiting
Toulon, France, 83000
Active, not recruiting
Toulouse, France, 31059
Active, not recruiting
Tourcoing, France, 59208
Active, not recruiting
Vandoeuvre-les-nancy, France, 54511
Active, not recruiting
Vannes, France, 56017
Active, not recruiting
Villejuif, France, 94804
Terminated
Villeneuve Maguelone, France, 34751
Active, not recruiting
Villeneuve St Georges, France, 94195
Germany
Completed
Aachen, Germany, 52074
Completed
Berlin, Germany, 10777
Completed
Berlin, Germany, 10243
Completed
Burghausen, Germany, 84489
Completed
Düsseldorf, Germany, 40237
Completed
Erlangen, Germany, 91054
Completed
Essen, Germany, 45122
Completed
Kassel, Germany, 34117
Completed
Köln, Germany, 50937
Completed
Lübeck, Germany, 23562
Completed
Magdeburg, Germany, 39120
Completed
Mannheim, Germany, 68167
Completed
Rostock, Germany, 18057
Completed
Rottenburg, Germany, 72108
Completed
Tübingen, Germany, 72076
Greece
Active, not recruiting
Alexandroupolis, Greece, 68100
Active, not recruiting
Athens, Greece, 11527
Active, not recruiting
Athens, Greece, 11522
Active, not recruiting
Athens, Greece, 115 27
Active, not recruiting
Ioannina, Greece, 455 00
Active, not recruiting
Larissa, Greece, 41 110
Active, not recruiting
Nea Kifissia, Greece, 14564
Active, not recruiting
Patra, Greece, 265 04
Active, not recruiting
Thessaloniki, Greece, 546 42
Hungary
Active, not recruiting
Ajka, Hungary, H-8400
Active, not recruiting
Balassagyarmat, Hungary, 2660
Active, not recruiting
Bekescsaba, Hungary, 5600
Active, not recruiting
Budapest, Hungary, 1088
Active, not recruiting
Budapest, Hungary, H-1125
Active, not recruiting
Budapest, Hungary, 1126
Active, not recruiting
Budapest, Hungary, 1067
Active, not recruiting
Budapest, Hungary, 1097
Active, not recruiting
Budapest, Hungary, 1083
Active, not recruiting
Debrecen, Hungary, 4032
Active, not recruiting
Debrecen, Hungary, H-4031
Active, not recruiting
Gyula, Hungary, 5700
Active, not recruiting
Kaposvar, Hungary, 7400
Terminated
Kecskemet, Hungary, 6000
Active, not recruiting
Miskolc, Hungary, H-3501
Active, not recruiting
Nyíregyháza, Hungary, 4400
Active, not recruiting
Pecs, Hungary, 7624
Active, not recruiting
Sopron, Hungary, 9400
Terminated
Szeged, Hungary, 6720
Active, not recruiting
Szekesfehervar, Hungary, 8000
Active, not recruiting
Szolnok, Hungary, 5000
Active, not recruiting
Szombathely, Hungary, 9700
Active, not recruiting
Székesfehérvár, Hungary, 8000
Active, not recruiting
Tatabánya, Hungary, 2800
Active, not recruiting
Zalaegerszeg, Hungary, 8900
Terminated
Zalaegerszeg, Hungary, 8901
Ireland
Active, not recruiting
Dublin, Ireland, 8
Active, not recruiting
Dublin, Ireland, 9
Active, not recruiting
Dublin, Ireland, 4
Italy
Active, not recruiting
Chieti, Abruzzo, Italy, 66013
Active, not recruiting
Reggio Calabria, Calabria, Italy, 89100
Active, not recruiting
Avellino, Campania, Italy, 83100
Active, not recruiting
Gragnano, Campania, Italy, 80054
Active, not recruiting
Marcianise, Campania, Italy, 81025
Active, not recruiting
Napoli, Campania, Italy, 80136
Active, not recruiting
Napoli, Campania, Italy, 80131
Active, not recruiting
Napoli, Campania, Italy, 80138
Active, not recruiting
Nocera Inferiore, Campania, Italy, 84014
Active, not recruiting
Nola, Campania, Italy, 80035
Active, not recruiting
Bologna, Emilia-Romagna, Italy, 40138
Active, not recruiting
Modena, Emilia-Romagna, Italy, 41100
Active, not recruiting
Parma, Emilia-Romagna, Italy, 43100
Active, not recruiting
Piacenza, Emilia-Romagna, Italy, 29121
Active, not recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Active, not recruiting
Roma, Lazio, Italy, 00152
Active, not recruiting
Roma, Lazio, Italy, 00161
Active, not recruiting
Roma, Lazio, Italy, 00149
Active, not recruiting
Roma, Lazio, Italy, 00165
Active, not recruiting
Roma, Lazio, Italy, 00189
Active, not recruiting
Genova, Liguria, Italy, 16132
Active, not recruiting
Savona, Liguria, Italy, 17100
Active, not recruiting
Busto Arsizio, Lombardia, Italy, 21052
Active, not recruiting
Milano, Lombardia, Italy, 20132
Active, not recruiting
Milano, Lombardia, Italy, 20157
Active, not recruiting
Milano, Lombardia, Italy, 20142
Active, not recruiting
Milano, Lombardia, Italy, 20122
Active, not recruiting
Milano, Lombardia, Italy, 20162
Completed
Milano, Lombardia, Italy, 20123
Active, not recruiting
Torrette Di Ancona, Marche, Italy, 60020
Active, not recruiting
Biella, Piemonte, Italy, 13900
Active, not recruiting
Cuorgnè (TO), Piemonte, Italy, 10082
Active, not recruiting
Omegna (VB), Piemonte, Italy, 28887
Active, not recruiting
Bari, Puglia, Italy, 70124
Active, not recruiting
Bisceglie, Puglia, Italy, 70052
Active, not recruiting
Castellana Grotte, Puglia, Italy, 70013
Active, not recruiting
San Giovanni Rotondo, Puglia, Italy, 71013
Active, not recruiting
Cagliari, Sardegna, Italy, 09042
Active, not recruiting
Cagliari, Sardegna, Italy, 09100
Active, not recruiting
Sassari, Sardegna, Italy, 07100
Active, not recruiting
Catania, Sicilia, Italy, 95126
Active, not recruiting
Catania, Sicilia, Italy, 95100
Completed
Messina, Sicilia, Italy, 98124
Active, not recruiting
Palermo, Sicilia, Italy, 90127
Completed
Palermo, Sicilia, Italy, 90127
Active, not recruiting
Arezzo, Toscana, Italy, 52100
Active, not recruiting
Firenze, Toscana, Italy, 50134
Active, not recruiting
Livorno, Toscana, Italy, 57124
Active, not recruiting
Padova, Veneto, Italy, 35128
Kuwait
Active, not recruiting
Safat, Kuwait, 13041
Lebanon
Active, not recruiting
Baabda, Lebanon, 50
Active, not recruiting
Beirut, Lebanon, 11-236
Active, not recruiting
Beirut, Lebanon
Active, not recruiting
Beirut, Lebanon, 99999
Active, not recruiting
Nabatieh, Lebanon
Active, not recruiting
Tripoli, Lebanon, 371 Tripoli
Macedonia, The Former Yugoslav Republic of
Active, not recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Morocco
Active, not recruiting
Casablanca, Morocco
Active, not recruiting
Casablanca, Morocco, 20100
Active, not recruiting
Casablanca, Morocco, 20000
Active, not recruiting
Fes, Morocco
Active, not recruiting
Marrakech, Morocco
Active, not recruiting
Rabat, Morocco, 504
Active, not recruiting
Rabat, Morocco, 62000
Oman
Active, not recruiting
Muscat, Oman, P.O Box 35
Pakistan
Active, not recruiting
Faisalabad, Pakistan
Active, not recruiting
Gujranwala, Pakistan
Active, not recruiting
Karachi, Pakistan
Active, not recruiting
Lahore, Pakistan, 20021
Active, not recruiting
Lahore, Pakistan
Active, not recruiting
Rawalpindi, Pakistan
Portugal
Active, not recruiting
Almada, Portugal, 2805-267
Active, not recruiting
Amadora, Portugal, 2700-020
Active, not recruiting
Aveiro, Portugal, 3810-096
Active, not recruiting
Beja, Portugal, 7801-849
Active, not recruiting
Coimbra, Portugal, 3041-801
Active, not recruiting
Faro, Portugal, 8000-386
Active, not recruiting
Lisboa, Portugal, 1649-035
Active, not recruiting
Lisboa, Portugal, 1349-019
Active, not recruiting
Porto, Portugal, 4099-001
Qatar
Active, not recruiting
Doha, Qatar, P.O.Box 3051
Romania
Active, not recruiting
Bucharest, Romania, 022328
Completed
Bucharest, Romania, 021105
Active, not recruiting
Cluj-napoca, Romania, 400162
Active, not recruiting
Constanta, Romania
Active, not recruiting
Iasi, Romania, 700554
Active, not recruiting
Iasi, Romania, 700620
Active, not recruiting
Timisoara, Romania, 300167
Saudi Arabia
Active, not recruiting
Holy Makkah, Saudi Arabia, 21583-Makkah P.O.Box-53356
Completed
Riyadh, Saudi Arabia, 11211
Completed
Riyadh, Saudi Arabia, 11159
Serbia
Active, not recruiting
Belgrade, Serbia, 11000
Active, not recruiting
Novi Sad, Serbia, 21000
Sweden
Active, not recruiting
Gävle, Sweden, 80187
Completed
Karlstad, Sweden, 65185
Active, not recruiting
Uppsala, Sweden, 75185
Switzerland
Active, not recruiting
Lugano, Switzerland, 6900
Active, not recruiting
St. Gallen, Switzerland, 9007
Syrian Arab Republic
Completed
Aleppo, Syrian Arab Republic, 6448
Taiwan
Active, not recruiting
Kaohsiung, Taiwan, 807
Completed
Kaohsiung, Taiwan, 00833
Completed
Taichung, Taiwan, 40447
Completed
Taipei, Taiwan, 100
Completed
Taipei, Taiwan, 112
Completed
Taoyuan, Taiwan, 333
Turkey
Completed
Adana, Turkey, 01100
Active, not recruiting
Ankara, Turkey, 06100
Completed
Ankara, Turkey, 06290
Completed
Ankara, Turkey
Active, not recruiting
Ankara, Turkey, 06800
Active, not recruiting
Hatay, Turkey, 31040
Active, not recruiting
Istanbul, Turkey, 34390
Active, not recruiting
ISTANBULt, Turkey
Active, not recruiting
Izmir, Turkey, 35100
Active, not recruiting
Kayseri, Turkey, 38039
Active, not recruiting
Mersin, Turkey, 33169
Active, not recruiting
Tokat, Turkey, 60250
Active, not recruiting
Trabzon, Turkey, 61080
United Arab Emirates
Active, not recruiting
Al Ain, United Arab Emirates, P.O.Box 1006
Active, not recruiting
Dubai, United Arab Emirates, 4545
Active, not recruiting
Sharjah, United Arab Emirates, P.O.Box: 5735 - Sharjah, UAE
United Kingdom
Active, not recruiting
Dundee, United Kingdom, DD1 9SY
Active, not recruiting
Hull, United Kingdom, HU3 2JZ
Active, not recruiting
London, United Kingdom, E1 1BB
Active, not recruiting
London, United Kingdom, W2 1NY
Active, not recruiting
Manchester, United Kingdom, M8 5RB
Active, not recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01447446     History of Changes
Other Study ID Numbers: MV25599
Study First Received: October 4, 2011
Last Updated: August 11, 2014
Health Authority: Syria: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 16, 2014