ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Drug: Pegylated Interferon Alfa-2a Drug: Ribavirin

Study Type : Observational
Actual Enrollment : 516 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia
Actual Study Start Date : April 6, 2011
Actual Primary Completion Date : October 20, 2015
Actual Study Completion Date : October 20, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.
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



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with chronic hepatitis C infection and naive to peginterferon/ribavirin treatment
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659567


Locations
Georgia
Hepatology Clinic Hepa
Tbilisi, Georgia, 0159
Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, Georgia, 0160
Ltd Mrcheveli
Tbilisi, Georgia, 0160
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01659567     History of Changes
Other Study ID Numbers: ML25544
First Posted: August 8, 2012    Key Record Dates
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs