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

Hepatitis C, Chronic Clinical Trial

— POMOSCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098097
• Other study ID #: P06011
• Status: Completed
• Phase: N/A
• First received: April 1, 2010
• Last updated: November 14, 2014
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee at the Federal Service on Surveillance in Healthcare and Social Development
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 963
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• Peginterferon alpha
Peginterferon alpha given in combination with ribavirin according to local labeling guidelines

Drug:
• Ribavirin
Ribavirin given in combination with peginterferon alpha according to local labeling guidelines

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Incidence of Thrombocytopenia	Thrombocytopenia is a low blood platelet count	Up to 12 Weeks	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	No