Clinical trial NCT01798576: An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure
Official title: Non-interventional, Observational Study on Retreatment of Chronic Hepatitis C Patients Previous Treatment Failure, Using Peginterferon Alfa-2a and Ribavirin Based Regimens
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Treatment-experienced participants with chronic hepatitis C receiving re-treatment with Pegasys plus ribavirin or regimens containing direct-acting antivirals (DAAs)

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: approximately 3 years
Secondary outcomes:
measure: 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)
timeFrame: approximately 3 years
measure: 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)
timeFrame: approximately 3 years
measure: Percentage of patients with non-response/relapse/virological breakthrough/virological rebound
timeFrame: approximately 3 years
measure: Duration of treatment
timeFrame: approximately 3 years
measure: Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds
timeFrame: approximately 3 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Brasov
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: