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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447446
First received: October 4, 2011
Last updated: February 10, 2017
Last verified: December 2016
  Purpose
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.

Condition Intervention
Hepatitis C, Chronic
Drug: Peg-IFN Alfa-2a
Drug: Peg-IFN Alfa-2b
Drug: Ribavirin
Drug: Boceprevir
Drug: Telaprevir

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:
  • Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) [ Time Frame: 24 weeks after end of treatment (up to 118 weeks) ]
    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.

  • Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) [ Time Frame: 12 weeks after end of treatment (up to 118 weeks) ]
    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.


Secondary Outcome Measures:
  • Virological Response at Various on Treatment Time Points and End of Treatment (EOT) [ Time Frame: Week 4, 12 and End of treatment (EOT) (up to 96 weeks) ]
    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.

  • Virological Relapse After End of Treatment [ Time Frame: Up to 24 weeks after EOT (up to 118 weeks) ]
    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).

  • Virological Breakthrough [ Time Frame: Up to EOT (up to 118 weeks) ]
    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.

  • Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions [ Time Frame: Up to first 12 weeks of treatment ]
    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.

  • 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 [ Time Frame: Up to 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.

  • Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) [ Time Frame: Up to 98 weeks ]
    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.

  • Duration of Overall Treatment [ Time Frame: Up to 118 weeks ]
    Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.

  • Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) [ Time Frame: Up to 118 weeks ]
  • Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV) [ Time Frame: Up to 72 weeks of treatment ]
    Participants who prolonged the treatment period from 72 weeks were not reported.

  • Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA) [ Time Frame: Up to 72 weeks of treatment ]
    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).

  • Percentage of Participants With Concomitant Medical Condition at Baseline [ Time Frame: Baseline ]
  • Percentage of Participants With Adverse Events (AE) [ Time Frame: Up to 118 weeks ]
    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.


Enrollment: 4442
Study Start Date: September 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
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.
Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
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.
Drug: Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Drug: Boceprevir
Boceprevir according to standard of care and in line with local labeling.
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.
Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Drug: Boceprevir
Boceprevir according to standard of care and in line with local labeling.
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.
Drug: Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Drug: Telaprevir
Telaprevir according to standard of care and in line with local labeling.
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.
Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Drug: Telaprevir
Telaprevir according to standard of care and in line with local labeling.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

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

  Hide Study Locations
Locations
Belgium
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, 6000
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
Egypt
Alexandria, Egypt, 0
Alexandria, Egypt
Cairo, Egypt, 0
Cairo, Egypt
Giza, Egypt
Tanta, Egypt
Estonia
Kohtla-Järve, Estonia, 31025
Pärnu, Estonia, 80010
Tallinn, Estonia, 10138
Tallinn, Estonia, 10617
Tartu, Estonia, 51014
France
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, 75571
Paris, France, 75651
Paris, France, 75679
Paris, France, 75908
Paris, France, 75970
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
Germany
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
Greece
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
Hungary
Ajka, Hungary, H-8400
Balassagyarmat, Hungary, 2660
Bekescsaba, Hungary, 5600
Budapest, Hungary, 1067
Budapest, Hungary, 1083
Budapest, Hungary, 1088
Budapest, Hungary, 1097
Budapest, Hungary, 1126
Budapest, Hungary, H-1125
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
Ireland
Dublin, Ireland, 4
Dublin, Ireland, 8
Dublin, Ireland, 9
Italy
Chieti, Abruzzo, Italy, 66013
Reggio Calabria, Calabria, Italy, 89100
Avellino, Campania, Italy, 83100
Gragnano, Campania, Italy, 80054
Marcianise, Campania, Italy, 81025
Napoli, Campania, Italy, 80131
Napoli, Campania, Italy, 80136
Napoli, Campania, Italy, 80138
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, 20122
Milano, Lombardia, Italy, 20123
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20142
Milano, Lombardia, Italy, 20157
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
Kuwait
Safat, Kuwait, 13041
Lebanon
Baabda, Lebanon, 50
Beirut, Lebanon, 11-236
Beirut, Lebanon, 99999
Beirut, Lebanon
Nabatieh, Lebanon
Tripoli, Lebanon, 371 Tripoli
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Morocco
Casablanca, Morocco, 20000
Casablanca, Morocco, 20100
Casablanca, Morocco
Fes, Morocco
Marrakech, Morocco
Rabat, Morocco, 504
Rabat, Morocco, 62000
Oman
Muscat, Oman, P.O Box 35
Pakistan
Faisalabad, Pakistan
Gujranwala, Pakistan
Karachi, Pakistan
Lahore, Pakistan, 20021
Lahore, Pakistan
Rawalpindi, Pakistan
Portugal
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
Qatar
Doha, Qatar, P.O.Box 3051
Romania
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
Serbia
Belgrade, Serbia, 11000
Novi Sad, Serbia, 21000
Sweden
Gävle, Sweden, 80187
Karlstad, Sweden, 65185
Uppsala, Sweden, 75185
Switzerland
Lugano, Switzerland, 6900
St. Gallen, Switzerland, 9007
Syrian Arab Republic
Aleppo, Syrian Arab Republic, 6448
Taiwan
Kaohsiung, Taiwan, 00833
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 40447
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
Turkey
Adana, Turkey, 01100
Ankara, Turkey, 06100
Ankara, Turkey, 06290
Ankara, Turkey, 06800
Ankara, Turkey
Hatay, Turkey, 31040
ISTANBULt, Turkey
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, E1 1BB
London, United Kingdom, W2 1NY
Manchester, United Kingdom, M8 5RB
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01447446     History of Changes
Other Study ID Numbers: MV25599
Study First Received: October 4, 2011
Results First Received: September 27, 2016
Last Updated: February 10, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017