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PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066819
First received: February 9, 2010
Last updated: June 27, 2016
Last verified: June 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) or peginterferon alfa-2b 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 <2000.

Condition Intervention
Hepatitis C, Chronic
Drug: Peginterferon alfa-2a [Pegasys]
Drug: Peginterferon alfa-2b [PegIntron®]

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 Type of Peginterferon and Genotype in Modified All Treated Population [ Time Frame: At 24 weeks (Wk) 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 HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Sustained Virological Response by Type of Peginterferon and 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and 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 population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and 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 and PEG-IFN alfa-2b. 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 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 and PEG-IFN alfa-2b. 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 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.


Secondary Outcome Measures:
  • Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time [ Time Frame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT ] [ Designated as safety issue: No ]
    Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (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 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time [ Time Frame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT ] [ Designated as safety issue: No ]
    Virological response (VR) 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment

  • Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time [ Time Frame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT ] [ Designated as safety issue: No ]
    Modified virological response (mVR) 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment

  • Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time [ Time Frame: At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT ] [ Designated as safety issue: No ]
    Modified virological response (mVR) 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 and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment

  • Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid 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 and PEG-IFN alfa-2b.

  • Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol 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-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 and PEG-IFN alfa-2b.

  • Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid 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 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 and PEG-IFN alfa-2b.

  • Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol 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 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 and PEG-IFN alfa-2b.

  • Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response 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 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 was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response 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 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 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 is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.

  • Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 [ Time Frame: At Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 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 Wk 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 Wk 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 and PEG-IFN alfa-2b.

  • Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 [ Time Frame: During first 12 weeks of treatment ] [ Designated as safety issue: No ]
    RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 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 Wk 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 Wk 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 and PEG-IFN alfa-2b.

  • 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 number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. 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: 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 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. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.

  • 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 the 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. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 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 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. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.


Enrollment: 1656
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: August 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/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Drug: Peginterferon alfa-2b [PegIntron®]
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 treatment at a medical centre
Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic hepatitis C
  • HIV HCV co-infection allowed
  • informed consent to data collection

Exclusion Criteria:

  • co-infection with 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: NCT01066819

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
Birmingham, Alabama, United States, 35249
Birmingham, Alabama, United States, 35294
Dothan, Alabama, United States, 36305
United States, California
Fresno, California, United States, 93721
La Jolla, California, United States, 92037-1030
Lancaster, California, United States, 93534
Loma Linda, California, United States, 92354
Long Beach, California, United States, 90822
Los Angeles, California, United States, 90048
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90095
Sacramento, California, United States, 95817
San Clemente, California, United States, 92679
San Diego, California, United States, 92103-8465
San Francisco, California, United States, 94115
San Mateo, California, United States, 94403
Torrance, California, United States, 90505
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford, Connecticut, United States, 06106
United States, Florida
Gainesville, Florida, United States, 32610-0214
Maitland, Florida, United States, 32751
Orlando, Florida, United States, 32803
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta, Georgia, United States, 30308
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
Marietta, Georgia, United States, 30060
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Lexington, Kentucky, United States, 40536-0298
United States, Louisiana
Baton Rouge, Louisiana, United States, 70890
New Orleans, Louisiana, United States, 70121
Opelousas, Louisiana, United States, 70520
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Springfield, Massachusetts, United States, 01103
Springfield, Massachusetts, United States, 01107-1635
Worcester, Massachusetts, United States, 01068
United States, Michigan
Detroit, Michigan, United States, 48201
Grand Rapids, Michigan, United States, 49506
United States, Mississippi
Jackson, Mississippi, United States, 39202
Tupelo, Mississippi, United States, 38801
United States, Missouri
St Louis, Missouri, United States, 63104
St Louis, Missouri, United States, 63110
Topeka, Missouri, United States, 66606
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Egg Harbour Township, New Jersey, United States, 08234
Hackensack, New Jersey, United States, 07601
Hillsborough, New Jersey, United States, 08844
Roseland, New Jersey, United States, 07068
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Bayside, New York, United States, 11358
Catskill, New York, United States, 12414
Flushing, New York, United States, 11355
New York, New York, United States, 10003
New York, New York, United States, 10016
Poughkeepsie, New York, United States, 12601
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville, North Carolina, United States, 28801
Chapel Hill, North Carolina, United States, 27599-7584
Charlotte, North Carolina, United States, 28211
Fayetteville, North Carolina, United States, 28304
Rocky Mount, North Carolina, United States, 27804
Winston-salem, North Carolina, United States, 27103
Winston-salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44106
Cleveland, Ohio, United States, 44109
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112-4481
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97227
Portland, Oregon, United States, 97239
United States, Pennsylvania
Camp Hill, Pennsylvania, United States, 17011
DuBois, Pennsylvania, United States, 15801
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Bristol, Tennessee, United States, 37620
Chattanooga, Tennessee, United States, 37403
Germantown, Tennessee, United States, 38138
Kingsport, Tennessee, United States, 37660
Nashville, Tennessee, United States, 37211
West Nashville, Tennessee, United States, 37205
United States, Texas
Dallas, Texas, United States, 75203
Galveston, Texas, United States, 77555
Harlingen, Texas, United States, 78550
Houston, Texas, United States, 77030
Houston, Texas, United States, 77074
Houston, Texas, United States, 77090
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78234
United States, Utah
Salt Lake City, Utah, United States, 84121
United States, Virginia
Charlottesville, Virginia, United States, 22908
Fairfax, Virginia, United States, 22031
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23298
United States, Washington
Seattle, Washington, United States, 98133
United States, West Virginia
Huntington, West Virginia, United States, 25701
United States, Wyoming
Casper, Wyoming, United States, 82609
Puerto Rico
Santurce, Puerto Rico, 00909
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: NCT01066819     History of Changes
Other Study ID Numbers: MV21542 
Study First Received: February 9, 2010
Results First Received: May 9, 2016
Last Updated: June 27, 2016
Health Authority: United States: Institutional Review Board

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
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016