Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Biological: Peginterferon alpha
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C of any genotype; Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response; Inclusion criteria listed on the approved label in each country; Willingness of the patient to participate and sign the Informed Consent Form. Exclusion Criteria: Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peginterferon alpha and ribavirin<br>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<br>* Peginterferon alpha given in combination with ribavirin according to local labeling guidelines<br>* Other names: MK-4031;Drug: Ribavirin<br>* Ribavirin given in combination with peginterferon alpha according to local labeling guidelines<br>* Other names: MK-8908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) | 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. | Up to 12 Weeks | 
| Incidence of Thrombocytopenia | Thrombocytopenia is a low blood platelet count | Up to 12 Weeks | 
| Incidence of Treatment Discontinuations Due to Adverse Events | All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs. | Up to 12 Weeks | 
| Incidence of Particular Adverse Events Resulting in Treatment Discontinuation | 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) | Up to 12 Weeks | 
| Incidence of Dose Modifications Due to Adverse Events | All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs. | Up to 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) | Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL. | Week 12 |