Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected With Chronic Hepatitis C Receiving a Long Acting Interferon Plus Ribavirin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 4,459
- Primary Endpoint
- Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin
Study Overview
Brief Summary
This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (according to local legislation)
- •Chronic hepatitis C
- •Treatment with long-acting interferon plus ribavirin
- •Quantifiable HCV RNA before initiation of treatment
- •No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label
Exclusion Criteria
- •End stage renal disease
- •Major organ transplantation
- •Concomitant therapy with telbivudine
- •Pregnant or breast-feeding females
- •Male partners of pregnant females
Outcomes
Primary Outcomes
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin
Time Frame: 4 years
Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment)
Time Frame: 4 years
Secondary Outcomes
- Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR(4 years)
- Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients(4 years)
- Safety: Incidence of adverse events(4 years)
- Correlation of on-treatment factors and dose reduction/treatment discontinuation(4 years)