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

February 10, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4442

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
      • Antwerpen, Belgium, 2018
      • Bouge, Belgium, 5004
      • Brussels, Belgium, 1000
      • Bruxelles, Belgium, 1020
      • Bruxelles, Belgium, 1070
      • Bruxelles, Belgium, 1200
      • Bruxelles, Belgium, 1180
      • Bruxelles, Belgium, 1190
      • 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
      • Alexandria, Egypt
      • Cairo, Egypt
      • Cairo, Egypt
      • Giza, Egypt
      • Tanta, Egypt
  • Estonia
      • Kohtla-Järve, Estonia, 31025
      • Pärnu, Estonia, 80010
      • Tallinn, Estonia, 10617
      • Tallinn, Estonia, 10138
      • 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, 34295
      • Montpellier, France, 34070
      • Nice, France, 06202
      • Nimes, France, 30029
      • Orange, France, 84100
      • Orleans, France, 45100
      • Paris, France, 75970
      • Paris, France, 75908
      • Paris, France, 75651
      • Paris, France, 75571
      • Paris, France, 75679
      • 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, 10777
      • Berlin, Germany, 10243
      • 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, 11527
      • Athens, Greece, 11522
      • 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, 1083
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1097
      • Budapest, Hungary, H-1125
      • Budapest, Hungary, 1067
      • Budapest, Hungary, 1126
      • 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, 9
      • Dublin, Ireland, 8
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89100
    • Campania
      • Avellino, Campania, Italy, 83100
      • Gragnano, Campania, Italy, 80054
      • Marcianise, Campania, Italy, 81025
      • Napoli, Campania, Italy, 80131
      • Napoli, Campania, Italy, 80138
      • Napoli, Campania, Italy, 80136
      • Nocera Inferiore, Campania, Italy, 84014
      • Nola, Campania, Italy, 80035
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
      • Modena, Emilia-Romagna, Italy, 41100
      • Parma, Emilia-Romagna, Italy, 43126
      • Piacenza, Emilia-Romagna, Italy, 29121
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
    • Lazio
      • Roma, Lazio, Italy, 00165
      • Roma, Lazio, Italy, 00152
      • Roma, Lazio, Italy, 00161
      • Roma, Lazio, Italy, 00149
      • Roma, Lazio, Italy, 00189
    • Liguria
      • Genova, Liguria, Italy, 16132
      • Savona, Liguria, Italy, 17100
    • Lombardia
      • Busto Arsizio, Lombardia, Italy, 21052
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20157
      • Milano, Lombardia, Italy, 20122
      • Milano, Lombardia, Italy, 20162
      • Milano, Lombardia, Italy, 20123
      • Milano, Lombardia, Italy, 20142
    • Marche
      • Torrette Di Ancona, Marche, Italy, 60020
    • Piemonte
      • Biella, Piemonte, Italy, 13900
      • Cuorgnè (TO), Piemonte, Italy, 10082
      • Omegna (VB), Piemonte, Italy, 28887
    • Puglia
      • Bari, Puglia, Italy, 70124
      • Bisceglie, Puglia, Italy, 70052
      • Castellana Grotte, Puglia, Italy, 70013
      • San Giovanni Rotondo, Puglia, Italy, 71013
    • Sardegna
      • Cagliari, Sardegna, Italy, 09042
      • Cagliari, Sardegna, Italy, 09100
      • Sassari, Sardegna, Italy, 07100
    • Sicilia
      • Catania, Sicilia, Italy, 95100
      • Catania, Sicilia, Italy, 95126
      • Messina, Sicilia, Italy, 98124
      • Palermo, Sicilia, Italy, 90127
    • Toscana
      • Arezzo, Toscana, Italy, 52100
      • Firenze, Toscana, Italy, 50134
      • Livorno, Toscana, Italy, 57124
    • Veneto
      • Padova, Veneto, Italy, 35128
  • Kuwait
      • Safat, Kuwait, 13041
  • Lebanon
      • Baabda, Lebanon, 50
      • Beirut, Lebanon, 99999
      • Beirut, Lebanon, 11-236
      • 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, 20100
      • Casablanca, Morocco
      • Casablanca, Morocco, 20000
      • 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, 1649-035
      • Lisboa, Portugal, 1349-019
      • 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, 11211
      • Riyadh, Saudi Arabia, 11159
  • 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
      • Ankara, Turkey, 06100
      • Ankara, Turkey, 06290
      • Ankara, Turkey, 06800
      • 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, W2 1NY
      • London, United Kingdom, E1 1BB
      • Manchester, United Kingdom, M8 5RB
      • Nottingham, United Kingdom, NG7 2UH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b 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: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b 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: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
12 weeks after end of treatment (up to 118 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
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).
Up to 24 weeks after EOT (up to 118 weeks)
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.
Up to EOT (up to 118 weeks)
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.
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
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.
Up to 12 weeks
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.
Up to 98 weeks
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.
Up to 118 weeks
Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
Time Frame: Up to 118 weeks
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.
Up to 72 weeks of treatment
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).
Up to 72 weeks of treatment
Percentage of Participants With Concomitant Medical Condition at Baseline
Time Frame: Baseline
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.
Up to 118 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MV25599

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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