Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)

October 1, 2015 updated by: Merck Sharp & Dohme LLC

Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin

The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with chronic hepatitis C treated with peginterferon alfa-2b and ribavirin at approximately 81 sites in the Czech Republic.

Description

Inclusion Criteria:

  • Participants with chronic hepatitis C
  • At least 18 years old
  • Eligibility determined based on the diagnosis and medical judgment only.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peginterferon alfa-2b and ribavirin
All participants included in the study
Biological: peginterferon alfa-2b
Peginterferon alfa-2b administered in accordance with approved labeling, ie, 1.5 μg/kg weekly SC for 48 weeks for participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.
Other Names:
  • SCH 054031
  • PegIntron
  • peginterferon α-2b
Drug: ribavirin
Ribavirin administered in accordance with approved labeling, ie, 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg, administered orally for 48 weeks for participants with HCV genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.
Other Names:
  • Rebetol
  • SCH 018908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category
Time Frame: From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.
From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Cost Per Participant With SVR Stratified by Ribavirin Dosage
Time Frame: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.
From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
Average Cost Per Participant With SVR Stratified by Prior Treatment Status
Time Frame: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.
From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04588

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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