An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01798576
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 282
-
Adult participants, >/= 18 years of age
-
Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
-
No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label
-
Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:
- Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)
- Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment
- No co-infection with hepatitis B or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
- History of neurological disease
- History of severe psychiatric disease
- Decompensated diabetes
- History of immunologically mediated disease
- History of severe cardiac disease
- History or evidence of severe chronic pulmonary disease
- Inadequate hematologic function
- Pregnant or breastfeeding women
- Male partners of pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pegylated interferon alfa-2a Pegylated Interferon alfa-2a Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs) Pegylated interferon alfa-2a Ribavirin Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs)
- Primary Outcome Measures
Name Time Method Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse) approximately 3 years
- Secondary Outcome Measures
Name Time Method Duration of treatment approximately 3 years Percentage of patients with non-response/relapse/virological breakthrough/virological rebound approximately 3 years Safety: Incidence of adverse events approximately 3 years Percentage of patients with rapid virological response (RVR), defined as HCV RNA <50 IU/mL at Week 4 (overall and stratified by prior treatment outcome: non-response and relapse) approximately 3 years Percentage of patients with early virological response (EVR), defined as HCV RNA <50 IU/mL or an at least 2-log drop from baseline in HCV RNA at Week 12, but with no RVR (overall and stratified by prior treatment outcome: non-response and relapse) approximately 3 years Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds approximately 3 years