Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011) (POMOSCH)
To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin|
- Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.
- Incidence of Thrombocytopenia [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]Thrombocytopenia is a low blood platelet count
- Incidence of Treatment Discontinuations Due to Adverse Events [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.
- Incidence of Particular Adverse Events Resulting in Treatment Discontinuation [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]
All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).
The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)
- Incidence of Dose Modifications Due to Adverse Events [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.
- Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.
|Study Start Date:||June 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Peginterferon alpha and ribavirin
Peginterferon alpha and ribavirin will be administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Biological: Peginterferon alpha
Peginterferon alpha given in combination with ribavirin according to local labeling guidelines
Other Names:Drug: Ribavirin
Ribavirin given in combination with peginterferon alpha according to local labeling guidelines
This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.