Clinical trial NCT01659567: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with chronic hepatitis C infection and naive to peginterferon/ribavirin treatment

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.


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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response (SVR)
timeFrame: At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks
measure: Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR
timeFrame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
measure: PPV of Complete Early Viral Response (cEVR) on SVR
timeFrame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
Secondary outcomes:
measure: Odds Ratio (OR) for Impact of Age on SVR
timeFrame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
measure: OR for Impact of Gender on SVR
timeFrame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
measure: OR for Impact of Body Weight on SVR
timeFrame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
measure: OR for Impact of Baseline Level of Fibrosis (kPa) on SVR
timeFrame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
measure: OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR
timeFrame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
measure: OR for Impact of Baseline Viral Load Count on SVR
timeFrame: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
measure: OR for Impact of Overall Duration of Treatment on SVR
timeFrame: Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)
measure: OR for Impact of Duration of Treatment After Achieving RVR on SVR
timeFrame: 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)
measure: OR for Impact of Duration of Treatment After Achieving cEVR on SVR
timeFrame: 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)
measure: OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR
timeFrame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
measure: OR for Impact of Cumulative Doses of Ribavirin on SVR
timeFrame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Hepatology Clinic Hepa
city: Tbilisi
country: Georgia
facility: Infectious Diseases, AIDS and Clinical Immunology Research Center
city: Tbilisi
country: Georgia
facility: Ltd Mrcheveli
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: