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PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01070550
First received: February 9, 2010
Last updated: May 9, 2016
Last verified: May 2016
  Purpose
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

Condition Intervention
Hepatitis C, Chronic
Drug: Peginterferon alfa-2a (Pegasys®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.


Secondary Outcome Measures:
  • Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time [ Time Frame: At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT ] [ Designated as safety issue: No ]
    Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time [ Time Frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT ] [ Designated as safety issue: No ]
    Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time [ Time Frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT ] [ Designated as safety issue: No ]
    Modified virological response was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time [ Time Frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT ] [ Designated as safety issue: No ]
    Modified virological response is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12 [ Time Frame: At Week 2, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.

  • Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12 [ Time Frame: Week 2, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.

  • Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12 [ Time Frame: Week 2, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.

  • Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12 [ Time Frame: Week 2, Week 4, and Week 12 ] [ Designated as safety issue: No ]
    Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.

  • Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12 [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 12, but no mRVR, Partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Week 12, but no RVR and no cEVR, Modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a.

  • Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12 [ Time Frame: At Week 4 and Week 12 ] [ Designated as safety issue: No ]
    RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Week 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.

  • Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment [ Time Frame: At 12 Weeks after EOT ] [ Designated as safety issue: No ]
    Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment [ Time Frame: At 12 weeks after EOT ] [ Designated as safety issue: No ]
    Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population [ Time Frame: At 24 weeks after EOT ] [ Designated as safety issue: No ]
    The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.


Enrollment: 4680
Study Start Date: June 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort
Participants chronically infected with the hepatitis C virus including Genotypes 1 to 6.
Drug: Peginterferon alfa-2a (Pegasys®)
Peginterferon (PEG-IFN) alfa-2a Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving peginterferon alfa-2a treatment at a medical centre
Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic hepatitis C
  • informed consent to data collection

Exclusion Criteria:

  • co-infection with HIV or Hepatitis B Virus (HBV)
  • previous treatment with peginterferon and/or ribavirin
  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: NCT01070550

  Hide Study Locations
Locations
Austria
Gratwein, Austria, 8112
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4010
Linz, Austria, 4020
Wien, Austria, 1030
Wien, Austria, 1090
Wien, Austria, 1100
Wien, Austria, 1160
Brazil
Salvador, BA, Brazil, 41110-170
Goiania, GO, Brazil, 74535170
Belo Horizonte, MG, Brazil, 31270-901
Belem, PA, Brazil, 66035-080
Recife, PE, Brazil, 50100-130
Recife, PE, Brazil, 50670-420
Rio de Janeiro, RJ, Brazil, 20270-004
Rio de Janeiro, RJ, Brazil, 20529-900
Rio de Janeiro, RJ, Brazil, 22410002
Porto Alegre, RS, Brazil, 90035-003
Rio Grande, RS, Brazil, 96200-310
Botucatu, SP, Brazil, 18600-400
Campinas, SP, Brazil, 13026-210
Campinas, SP, Brazil, 13081-970
Ribeirao Preto, SP, Brazil, 14085-410
Santos, SP, Brazil, 11015470
Sao Paulo, SP, Brazil, 01246-900
Sao Paulo, SP, Brazil, 01246-903
Sao Paulo, SP, Brazil, 04040-002
Sao Paulo, SP, Brazil, 1246-000
Sao Paulo, SP, Brazil, 1323020
Sao Paulo, SP, Brazil, 4029000
Canada, Alberta
Calgary, Alberta, Canada, T2G 0H5
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 1T2
Nanaimo, British Columbia, Canada, V9R 5N9
New Westminster, British Columbia, Canada, V3L 3W5
Prince George, British Columbia, Canada, V2M 5J6
Vancouver, British Columbia, Canada, V6Z 2C7
Victoria, British Columbia, Canada, V8R 6R3
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2W 5L4
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1E 2Z1
Canada, Ontario
Barrie, Ontario, Canada, L4M 5G1
Brampton, Ontario, Canada, L6S 1C0
Etobicoke, Ontario, Canada, M9V 4B8
Guelph, Ontario, Canada, N1E 6Z1
London, Ontario, Canada, N6A 5R9
Newmarket, Ontario, Canada, L3Y 2P6
North Bay, Ontario, Canada, P1B 2H3
Oakville, Ontario, Canada, L6J 1X8
Oshawa, Ontario, Canada, L1G 2B9
Oshawa, Ontario, Canada, L1J 2J9
Ottawa, Ontario, Canada, K2B 8E8
Scarborough, Ontario, Canada, M1T 3V3
Sudbury, Ontario, Canada, P3E 1B8
Toronto, Ontario, Canada, M5A 1L5
Toronto, Ontario, Canada, M6A 3B2
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Levis, Quebec, Canada, G6V 3Z1
Montreal, Quebec, Canada, H2L 4P9
Montreal, Quebec, Canada, H2L 5B1
Quebec City, Quebec, Canada, G1L 3L5
Quebec City, Quebec, Canada, G1R 1S9
Quebec City, Quebec, Canada, QC G1S 4L8
Saint-jean Sur Richelieu, Quebec, Canada, J2X 4C7
St-charles Borromee, Quebec, Canada, J6E 2C3
Croatia
Osijek, Croatia, 31000
Pula, Croatia, 52000
Split, Croatia, 21000
Zadar, Croatia, 23000
Zagreb, Croatia, 10000
France
Agen, France, 47002
Aix En Provence, France, 13616
Albi, France, 81000
Amiens, France, 80054
Angers, France, 49033
Annecy, France, 74000
Antibes, France, 06600
Argenteuil, France, 95100
Argenteuil, France, 95107
Aulnay Sous Bois, France, 93600
Aulnay Sous Bois, France, 93602
Bastia, France, 20200
Beaumont, France, 63110
Beausoleil, France, 06240
Beauvais, France, 60021
Besancon, France, 25000
Besancon, France, 25030
Beziers, France, 34500
Beziers, France, 34525
Bordeaux, France, 33000
Bordeaux, France, 33300
Boulogne Billancourt, France, 92104
Bourgoin Jallieu, France, 38317
Caen, France, 14033
Chambery, France, 73000
Clermont Ferrand, France, 63023
Clichy, France, 92118
Colmar, France, 68024
Cornebarrieu, France, 31700
Creil, France, 60100
Creteil, France, 94000
Creteil, France, 94010
Dijon, France, 21000
Dijon, France, 21079
Druex, France, 28107
Evreux, France, 27000
Frejus, France, 83608
Freyming Merlebach, France, 57800
Grasse, France, 06130
Grenoble, France, 38043
Herouville St Clair, France, 14200
Hyeres, France, 83400
La Rochelle, France, 17100
La Valette du Var, France, 83160
Lagny Sur Marne, France, 77405
Le Chesnay, France, 78157
Le Havre, France, 76600
Le Kremlin Bicetre, France, 94276
Lille, France, 59037
Limoges, France, 87042
Lomme, France, 59160
Lorient, France, 56322
Lyon, France, 69009
Lyon, France, 69288
Lyon, France, 69437
Marseille, France, 13002
Marseille, France, 13013
Marseille, France, 13015
Marseille, France, 13285
Marseille, France, 13385
Martigues, France, 13500
Meaux, France, 77104
Melun, France, 77011
Menton, France, 06507
Metz, France, 57038
Metz, France, 57045
Monaco, France, 98012
Montauban, France, 82013
Montpellier, France, 34000
Montpellier, France, 34295
Mulhouse, France, 68070
Muret, France, 31607
Nanterre, France, 92000
Nantes, France, 44000
Nantes, France, 44035
Nice, France, 06000
Nice, France, 06202
Nimes, France, 30029
Nimes, France, 30900
Ollioules, France, 83190
Orange, France, 84100
Orleans, France, 45100
Paris, France, 75014
Paris, France, 75018
Paris, France, 75571
Paris, France, 75651
Paris, France, 75970
Perigueux, France, 24019
Perpignan, France, 66046
Pessac, France, 33604
Poissy, France, 78303
Poitiers, France, 86021
Pont a Mousson, France, 54700
Reims, France, 51092
Rennes, France, 35033
Rouen, France, 76031
Saint Laurent Du Var, France, 06700
Sete, France, 34207
St Dizier, France, 52115
St Jean De Verges, France, 09000
St Mande, France, 94163
Ste Maxime, France, 83120
Strasbourg, France, 67091
Tarbes, France, 65951
Toulon, France, 83000
Toulouse, France, 31054
Toulouse, France, 31059
Toulouse, France, 31076
Toulouse, France, 31077
Tourcoing, France, 59200
Valenciennes, France, 59322
Vandoeuvre-les-nancy, France, 54511
Villejuif, France, 94804
Hungary
Ajka, Hungary, H-8400
Bekescsaba, Hungary, 5600
Budapest, Hungary, 1083
Budapest, Hungary, 1088
Budapest, Hungary, 1097
Budapest, Hungary, 1135
Budapest, Hungary, H-1125
Debrecen, Hungary, 4032
Debrecen, Hungary, H-4031
Eger, Hungary, 3300
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Kecskemet, Hungary, 6000
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3529
Miskolc, Hungary, H-3501
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7623
Pecs, Hungary, 7654
Szeged, Hungary, 6720
Szekszard, Hungary, 7100
Szolnok, Hungary, 5000
Szombathely, Hungary, 9700
Székesfehérvár, Hungary, 8000
Tatabánya, Hungary, 2800
Zalaegerszeg, Hungary, 8900
Zalaegerszeg, Hungary, 8901
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Chihuahua, Mexico, 31000
Chihuahua, Mexico, 31170
Culiacan, Mexico, 80230
Guadalajara, Mexico, 44650
Hermosillo, Mexico, 83150
Mexicali, Mexico, 21000
Mexico City, Mexico, 14050
Mexico DF, Mexico, 11649
Monterrey, Mexico, 64710
Puebla, Mexico, 72550
Puebla, Mexico, 72560
Morocco
Casablanca, Morocco, 20000
Casablanca, Morocco, 20100
Rabat, Morocco, 504
Poland
Bydgoszcz, Poland, 85-030
Lodz, Poland, 91-347
Warszawa, Poland, 01-201
Warszawa, Poland, 02-507
Wroclaw, Poland, 51-124
Romania
Arad, Romania, 310037
Brasov, Romania, 500007
Brasov, Romania, 500174
Brasov, Romania, 500326
Bucharest, Romania, 005098
Bucharest, Romania, 010825
Bucharest, Romania, 020475
Bucharest, Romania, 021105
Bucharest, Romania, 022328
Bucharest, Romania, 030303
Bucharest, Romania, 21105
Cluj Napoca, Romania, 400015
Cluj-napoca, Romania, 400162
Constanta, Romania, 8700
Constanta, Romania, 900900
Constanta, Romania
Iasi, Romania, 700111
Iasi, Romania, 700116
Sector 2, Romania, 020125
Targu-Mures, Romania, 540136
Timisoara, Romania, 293406
Timisoara, Romania, 300310
Serbia
Belgrade, Serbia, 11000
NIS, Serbia, 18000
Novi Sad, Serbia, 21000
Slovenia
Celje, Slovenia, 3000
Ljubljana, Slovenia, 1000
Maribor, Slovenia, 2000
Novo Mesto, Slovenia, 8000
Sweden
Eskilstuna, Sweden, 63188
Halmstad, Sweden, S301 85
Huddinge, Sweden, 14186
Linkoeping, Sweden, 58185
Lund, Sweden, 22185
Oerebro, Sweden, 70185
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01070550     History of Changes
Other Study ID Numbers: MV21012 
Study First Received: February 9, 2010
Results First Received: May 9, 2016
Last Updated: May 9, 2016
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016