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

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

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 Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Biological: Peginterferon alpha; Drug: Ribavirin

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 963

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: SCH 054031; MK-4031; PegIntron; Drug: Ribavirin; Ribavirin given in combination with peginterferon alpha according to local labeling guidelines; Other Names: Rebetol; SCH 018908; MK-8908

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: April 1, 2010
• First Submitted That Met QC Criteria: April 1, 2010
• First Posted (ESTIMATE): April 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: P06011