An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
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
1 other identifier
observational
4,442
26 countries
268
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Longer than P75 for all trials
268 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
March 30, 2017
CompletedMarch 30, 2017
December 1, 2016
3.8 years
October 4, 2011
September 27, 2016
February 10, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
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)
Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
Virological Relapse After End of Treatment
Up to 24 weeks after EOT (up to 118 weeks)
Virological Breakthrough
Up to EOT (up to 118 weeks)
Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
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
Up to 12 weeks
- +7 more secondary outcomes
Study Arms (6)
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.
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.
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.
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.
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.
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.
Interventions
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Ribavirin according to standard of care and in line with local labeling.
Boceprevir according to standard of care and in line with local labeling.
Telaprevir according to standard of care and in line with local labeling.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Contraindications according to SPC/local labeling
- Treatment started \>4 weeks before entering study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (271)
Unknown Facility
Antwerp, 2018, Belgium
Unknown Facility
Antwerp, 2060, Belgium
Unknown Facility
Bouge, 5004, Belgium
Unknown Facility
Brussels, 1000, Belgium
Unknown Facility
Brussels, 1020, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Brussels, 1180, Belgium
Unknown Facility
Brussels, 1190, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Gilly (Charleroi), 6000, Belgium
Unknown Facility
Hasselt, 3500, Belgium
Unknown Facility
Heusy, 4802, Belgium
Unknown Facility
Kortrijk, 8500, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Mons, 7000, Belgium
Unknown Facility
Montignies-sur-Sambre, 6061, Belgium
Unknown Facility
Namur, 5000, Belgium
Unknown Facility
Ostend, 8400, Belgium
Unknown Facility
Roeselare, 8800, Belgium
Unknown Facility
Verviers, 4800, Belgium
Unknown Facility
Alexandria, 0, Egypt
Unknown Facility
Alexandria, Egypt
Unknown Facility
Cairo, 0, Egypt
Unknown Facility
Cairo, Egypt
Unknown Facility
Giza, Egypt
Unknown Facility
Tanta, Egypt
Unknown Facility
Kohtla-Järve, 31025, Estonia
Unknown Facility
Pärnu, 80010, Estonia
Unknown Facility
Tallinn, 10138, Estonia
Unknown Facility
Tallinn, 10617, Estonia
Unknown Facility
Tartu, 51014, Estonia
Unknown Facility
Aix-en-Provence, 13616, France
Unknown Facility
Amiens, 80054, France
Unknown Facility
Argenteuil, 95107, France
Unknown Facility
Avignon, 84902, France
Unknown Facility
Besançon, 25000, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Béziers, 34500, France
Unknown Facility
Boulogne-Billancourt, 92104, France
Unknown Facility
Bourgoin, 38300, France
Unknown Facility
Caen, 14033, France
Unknown Facility
Chambray-lès-Tours, 37171, France
Unknown Facility
Clichy, 92118, France
Unknown Facility
Creil, 60109, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Épinay-sur-Seine, 93806, France
Unknown Facility
Évry, 91014, France
Unknown Facility
Freyming-Merlebach, 57804, France
Unknown Facility
Gonesse, 95503, France
Unknown Facility
Grasse, 06130, France
Unknown Facility
Hyères, 83407, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
Lagny-sur-Marne, 77405, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Lomme, 59462, France
Unknown Facility
Lyon, 69009, France
Unknown Facility
Mantes-la-Jolie, 78200, France
Unknown Facility
Marseille, 13285, France
Unknown Facility
Meaux, 77104, France
Unknown Facility
Montpellier, 34070, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Nîmes, 30029, France
Unknown Facility
Orange, 84100, France
Unknown Facility
Orléans, 45100, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Paris, 75908, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Pau, 64046, France
Unknown Facility
Perpignan, 66046, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Reims, 51092, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Rouen, 76031, France
Unknown Facility
Saint-Laurent-du-Var, 06700, France
Unknown Facility
Saint-Nazaire, 44606, France
Unknown Facility
Saint-Priest-en-Jarez, 42277, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Suresnes, 92151, France
Unknown Facility
Toulon, 83000, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Tourcoing, 59208, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Vannes, 56017, France
Unknown Facility
Villejuif, 94804, France
Unknown Facility
Villeneuve Maguelone, 34751, France
Unknown Facility
Villeneuve-Saint-Georges, 94195, France
Unknown Facility
Aachen, 52074, Germany
Unknown Facility
Berlin, 10243, Germany
Unknown Facility
Berlin, 10777, Germany
Unknown Facility
Burghausen, 84489, Germany
Unknown Facility
Cologne, 50937, Germany
Unknown Facility
Düsseldorf, 40237, Germany
Unknown Facility
Erlangen, 91054, Germany
Unknown Facility
Essen, 45122, Germany
Unknown Facility
Kassel, 34117, Germany
Unknown Facility
Lübeck, 23562, Germany
Unknown Facility
Magdeburg, 39120, Germany
Unknown Facility
Mannheim, 68167, Germany
Unknown Facility
Rostock, 18057, Germany
Unknown Facility
Rottenburg, 72108, Germany
Unknown Facility
Tübingen, 72076, Germany
Unknown Facility
Alexandroupoli, 68100, Greece
Unknown Facility
Athens, 115 27, Greece
Unknown Facility
Athens, 11522, Greece
Unknown Facility
Athens, 11527, Greece
Unknown Facility
Ioannina, 455 00, Greece
Unknown Facility
Larissa, 41 110, Greece
Unknown Facility
Nea Kifissia, 14564, Greece
Unknown Facility
Pátrai, 265 04, Greece
Unknown Facility
Thessaloniki, 546 42, Greece
Unknown Facility
Ajka, H-8400, Hungary
Unknown Facility
Balassagyarmat, 2660, Hungary
Unknown Facility
Békéscsaba, 5600, Hungary
Unknown Facility
Budapest, 1067, Hungary
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1088, Hungary
Unknown Facility
Budapest, 1097, Hungary
Unknown Facility
Budapest, 1126, Hungary
Unknown Facility
Budapest, H-1125, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Debrecen, H-4031, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Kaposvár, 7400, Hungary
Unknown Facility
Kecskemét, 6000, Hungary
Unknown Facility
Miskolc, H-3501, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Pécs, 7624, Hungary
Unknown Facility
Sopron, 9400, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Szolnok, 5000, Hungary
Unknown Facility
Szombathely, 9700, Hungary
Unknown Facility
Tatabánya, 2800, Hungary
Unknown Facility
Zalaegerszeg, 8900, Hungary
Unknown Facility
Zalaegerszeg, 8901, Hungary
Unknown Facility
Dublin, 4, Ireland
Unknown Facility
Dublin, 8, Ireland
Unknown Facility
Dublin, 9, Ireland
Unknown Facility
Chieti, Abruzzo, 66013, Italy
Unknown Facility
Bari, Apulia, 70124, Italy
Unknown Facility
Bisceglie, Apulia, 70052, Italy
Unknown Facility
Castellana Grotte, Apulia, 70013, Italy
Unknown Facility
San Giovanni Rotondo, Apulia, 71013, Italy
Unknown Facility
Reggio Calabria, Calabria, 89100, Italy
Unknown Facility
Avellino, Campania, 83100, Italy
Unknown Facility
Gragnano, Campania, 80054, Italy
Unknown Facility
Marcianise, Campania, 81025, Italy
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Napoli, Campania, 80136, Italy
Unknown Facility
Napoli, Campania, 80138, Italy
Unknown Facility
Nocera Inferiore, Campania, 84014, Italy
Unknown Facility
Nola, Campania, 80035, Italy
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Modena, Emilia-Romagna, 41100, Italy
Unknown Facility
Parma, Emilia-Romagna, 43126, Italy
Unknown Facility
Piacenza, Emilia-Romagna, 29121, Italy
Unknown Facility
Udine, Friuli Venezia Giulia, 33100, Italy
Unknown Facility
Rome, Lazio, 00149, Italy
Unknown Facility
Rome, Lazio, 00152, Italy
Unknown Facility
Rome, Lazio, 00161, Italy
Unknown Facility
Rome, Lazio, 00165, Italy
Unknown Facility
Rome, Lazio, 00189, Italy
Unknown Facility
Genoa, Liguria, 16132, Italy
Unknown Facility
Savona, Liguria, 17100, Italy
Unknown Facility
Busto Arsizio, Lombardy, 21052, Italy
Unknown Facility
Milan, Lombardy, 20122, Italy
Unknown Facility
Milan, Lombardy, 20123, Italy
Unknown Facility
Milan, Lombardy, 20132, Italy
Unknown Facility
Milan, Lombardy, 20142, Italy
Unknown Facility
Milan, Lombardy, 20157, Italy
Unknown Facility
Milan, Lombardy, 20162, Italy
Unknown Facility
Biella, Piedmont, 13900, Italy
Unknown Facility
Cuorgnè (TO), Piedmont, 10082, Italy
Unknown Facility
Omegna (VB), Piedmont, 28887, Italy
Unknown Facility
Cagliari, Sardinia, 09042, Italy
Unknown Facility
Cagliari, Sardinia, 09100, Italy
Unknown Facility
Sassari, Sardinia, 07100, Italy
Unknown Facility
Catania, Sicily, 95100, Italy
Unknown Facility
Catania, Sicily, 95126, Italy
Unknown Facility
Messina, Sicily, 98124, Italy
Unknown Facility
Palermo, Sicily, 90127, Italy
Unknown Facility
Torrette Di Ancona, The Marches, 60020, Italy
Unknown Facility
Arezzo, Tuscany, 52100, Italy
Unknown Facility
Florence, Tuscany, 50134, Italy
Unknown Facility
Livorno, Tuscany, 57124, Italy
Unknown Facility
Padua, Veneto, 35128, Italy
Unknown Facility
Safat, 13041, Kuwait
Unknown Facility
Baabda, 50, Lebanon
Unknown Facility
Beirut, 11-236, Lebanon
Unknown Facility
Beirut, 99999, Lebanon
Unknown Facility
Beirut, Lebanon
Unknown Facility
Nabatieh, Lebanon
Unknown Facility
Tripoli, 371 Tripoli, Lebanon
Unknown Facility
Casablanca, 20000, Morocco
Unknown Facility
Casablanca, 20100, Morocco
Unknown Facility
Casablanca, Morocco
Unknown Facility
Fes, Morocco
Unknown Facility
Marrakesh, Morocco
Unknown Facility
Rabat, 504, Morocco
Unknown Facility
Rabat, 62000, Morocco
Unknown Facility
Skopje, 1000, North Macedonia
Unknown Facility
Muscat, P.O Box 35, Oman
Unknown Facility
Faisalabad, Pakistan
Unknown Facility
Gujranwala, Pakistan
Unknown Facility
Karachi, Pakistan
Unknown Facility
Lahore, 20021, Pakistan
Unknown Facility
Lahore, Pakistan
Unknown Facility
Rawalpindi, Pakistan
Unknown Facility
Almada, 2805-267, Portugal
Unknown Facility
Amadora, 2700-020, Portugal
Unknown Facility
Aveiro, 3810-096, Portugal
Unknown Facility
Beja, 7801-849, Portugal
Unknown Facility
Coimbra, 3041-801, Portugal
Unknown Facility
Faro, 8000-386, Portugal
Unknown Facility
Lisbon, 1349-019, Portugal
Unknown Facility
Lisbon, 1649-035, Portugal
Unknown Facility
Porto, 4099-001, Portugal
Unknown Facility
Doha, P.O.Box 3051, Qatar
Unknown Facility
Bucharest, 021105, Romania
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Cluj-Napoca, 400162, Romania
Unknown Facility
Constanța, Romania
Unknown Facility
Iași, 700554, Romania
Unknown Facility
Iași, 700620, Romania
Unknown Facility
Timișoara, 300167, Romania
Unknown Facility
Holy Makkah, 21583-Makkah P.O.Box-53356, Saudi Arabia
Unknown Facility
Riyadh, 11159, Saudi Arabia
Unknown Facility
Riyadh, 11211, Saudi Arabia
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Novi Sad, 21000, Serbia
Unknown Facility
Gävle, 80187, Sweden
Unknown Facility
Karlstad, 65185, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Unknown Facility
Lugano, 6900, Switzerland
Unknown Facility
Sankt Gallen, 9007, Switzerland
Unknown Facility
Aleppo, 6448, Syria
Unknown Facility
Kaohsiung City, 00833, Taiwan
Unknown Facility
Kaohsiung City, 807, Taiwan
Unknown Facility
Taichung, 40447, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taipei, 112, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Unknown Facility
Adana, 01100, Turkey (Türkiye)
Unknown Facility
Ankara, 06100, Turkey (Türkiye)
Unknown Facility
Ankara, 06290, Turkey (Türkiye)
Unknown Facility
Ankara, 06800, Turkey (Türkiye)
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Hatay, 31040, Turkey (Türkiye)
Unknown Facility
Istanbul, 34390, Turkey (Türkiye)
Unknown Facility
ISTANBULt, Turkey (Türkiye)
Unknown Facility
Izmir, 35100, Turkey (Türkiye)
Unknown Facility
Kayseri, 38039, Turkey (Türkiye)
Unknown Facility
Mersin, 33169, Turkey (Türkiye)
Unknown Facility
Tokat Province, 60250, Turkey (Türkiye)
Unknown Facility
Trabzon, 61080, Turkey (Türkiye)
Unknown Facility
Al Ain City, P.O.Box 1006, United Arab Emirates
Unknown Facility
Dubai, 4545, United Arab Emirates
Unknown Facility
Sharjah city, P.O.Box: 5735 - Sharjah, UAE, United Arab Emirates
Unknown Facility
Dundee, DD1 9SY, United Kingdom
Unknown Facility
Hull, HU3 2JZ, United Kingdom
Unknown Facility
London, E1 1BB, United Kingdom
Unknown Facility
London, W2 1NY, United Kingdom
Unknown Facility
Manchester, M8 5RB, United Kingdom
Unknown Facility
Nottingham, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 6, 2011
Study Start
September 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
March 30, 2017
Results First Posted
March 30, 2017
Record last verified: 2016-12