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A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C

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ClinicalTrials.gov Identifier: NCT01659567
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date July 27, 2012
First Posted Date August 8, 2012
Results First Submitted Date May 5, 2017
Results First Posted Date October 3, 2017
Last Update Posted Date October 3, 2017
Actual Study Start Date April 6, 2011
Actual Primary Completion Date October 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2017)
  • Percentage of Participants Achieving Sustained Virological Response (SVR) [ Time Frame: At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks ]
    SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.
  • Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR [ Time Frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks ]
    RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • PPV of Complete Early Viral Response (cEVR) on SVR [ Time Frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks ]
    cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Original Primary Outcome Measures
 (submitted: August 7, 2012)
Predictive values of sustained virological response [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2017)
  • Odds Ratio (OR) for Impact of Age on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Gender on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Body Weight on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Baseline Level of Fibrosis (kPa) on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Baseline Viral Load Count on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Overall Duration of Treatment on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Duration of Treatment After Achieving RVR on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Duration of Treatment After Achieving cEVR on SVR [ Time Frame: Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR [ Time Frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
  • OR for Impact of Cumulative Doses of Ribavirin on SVR [ Time Frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks ]
    The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Original Secondary Outcome Measures
 (submitted: August 7, 2012)
  • Correlation of patient characteristics and sustained virological response [ Time Frame: 48 weeks ]
  • Overall treatment duration [ Time Frame: 48 weeks ]
  • Treatment duration after sustained virological response [ Time Frame: 48 weeks ]
  • Correlation of treatment dose and sustained virological response [ Time Frame: 48 weeks ]
  • Sustained virological response [ Time Frame: Week 24 ]
  • Safety: incidence of adverse events [ Time Frame: 72 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C
Official Title Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia
Brief Summary This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult participants with chronic hepatitis C infection and naive to peginterferon/ribavirin treatment
Condition Hepatitis C, Chronic
Intervention
  • Drug: Pegylated Interferon Alfa-2a
    Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.
    Other Name: Pegasys
  • Drug: Ribavirin
    Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.
    Other Name: Copegus
Study Groups/Cohorts Chronic Hepatitis C
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.
Interventions:
  • Drug: Pegylated Interferon Alfa-2a
  • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 5, 2017)
516
Original Estimated Enrollment
 (submitted: August 7, 2012)
300
Actual Study Completion Date October 20, 2015
Actual Primary Completion Date October 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- Diagnosis of chronic hepatitis C infection

Exclusion Criteria:

  • Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
  • Participants previously treated with pegylated interferon alfa-2a/ribavirin
  • Participation in another clinical study within 30 days prior to study start of ML25544
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Georgia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01659567
Other Study ID Numbers ML25544
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2017