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

• 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: Hoffmann-La Roche
• 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 ]

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

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

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