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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)

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ClinicalTrials.gov Identifier: NCT00723632
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : December 20, 2011
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Hepatitis C Biological: peginterferon alfa-2b Drug: ribavirin

Study Design

Study Type : Observational
Actual Enrollment : 901 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin
Study Start Date : September 2005
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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:
  • SCH 018908
  • Rebetol


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723632     History of Changes
Other Study ID Numbers: P04588
First Posted: July 29, 2008    Key Record Dates
Results First Posted: December 20, 2011
Last Update Posted: October 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs