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

June 27, 2016 updated by: Hoffmann-La Roche

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

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.

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.
1656

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

  • Puerto Rico
      • Santurce, Puerto Rico, 00909
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Birmingham, Alabama, United States, 35233
      • Birmingham, Alabama, United States, 35249
      • Dothan, Alabama, United States, 36305
    • 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, 90095
      • Los Angeles, California, United States, 90057
      • 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
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • Hartford, Connecticut, United States, 06106
    • Florida
      • Gainesville, Florida, United States, 32610-0214
      • Maitland, Florida, United States, 32751
      • Orlando, Florida, United States, 32806
      • Orlando, Florida, United States, 32803
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Decatur, Georgia, United States, 30033
      • Macon, Georgia, United States, 31201
      • Marietta, Georgia, United States, 30060
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60612
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0298
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70890
      • New Orleans, Louisiana, United States, 70121
      • Opelousas, Louisiana, United States, 70520
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Baltimore, Maryland, United States, 21229
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Springfield, Massachusetts, United States, 01103
      • Springfield, Massachusetts, United States, 01107-1635
      • Worcester, Massachusetts, United States, 01068
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Grand Rapids, Michigan, United States, 49506
    • Mississippi
      • Jackson, Mississippi, United States, 39202
      • Tupelo, Mississippi, United States, 38801
    • Missouri
      • St Louis, Missouri, United States, 63110
      • St Louis, Missouri, United States, 63104
      • Topeka, Missouri, United States, 66606
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • 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
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • 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, 10016
      • New York, New York, United States, 10003
      • Poughkeepsie, New York, United States, 12601
      • Syracuse, New York, United States, 13210
    • 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
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44109
      • Cleveland, Ohio, United States, 44195
      • Cleveland, Ohio, United States, 44106
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112-4481
      • Tulsa, Oklahoma, United States, 74135
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97227
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
      • DuBois, Pennsylvania, United States, 15801
      • Pittsburgh, Pennsylvania, United States, 15213
    • 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
    • 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
    • Utah
      • Salt Lake City, Utah, United States, 84121
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Fairfax, Virginia, United States, 22031
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23298
    • Washington
      • Seattle, Washington, United States, 98133
    • West Virginia
      • Huntington, West Virginia, United States, 25701
    • Wyoming
      • Casper, Wyoming, United States, 82609

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

Patients receiving peginterferon alfa treatment at a medical centre

Description

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

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

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.
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.

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 by Type of Peginterferon and Genotype in Per Protocol Population
Time Frame: At 24 weeks after EOT
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.
At 24 weeks after EOT
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
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.
At 24 weeks after EOT
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
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.
At 24 weeks (Wk) after EOT
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
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.
At 24 weeks after EOT
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
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.
At 24 weeks after EOT
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
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.
At 24 weeks after EOT

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
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
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.
At 12 weeks after EOT
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
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.
At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
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
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
At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
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
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
At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
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
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
At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT
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
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.
At Week 2, Week 4 and Week 12
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
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.
At Week 2, Week 4 and Week 12
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
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.
At Week 2, Week 4 and Week 12
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
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.
At Week 2, Week 4 and Week 12
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
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.
At 24 weeks after EOT
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
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.
At 24 weeks after EOT
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
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.
At Week 4 and Week 12
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
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.
During first 12 weeks 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
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'.
24 weeks after EOT
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
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.
At 12 weeks after EOT
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
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'.
At 24 weeks after EOT

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2008

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.
August 1, 2011

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.
August 1, 2011

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).
February 9, 2010

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.
February 9, 2010

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.
February 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

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.
August 8, 2016

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.
June 27, 2016

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.
June 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.
  • MV21542

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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