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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00723632
First received: July 25, 2008
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 Intervention
Hepatitis C, Chronic
Hepatitis C
Biological: peginterferon alfa-2b
Drug: ribavirin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 901
Study Start Date: September 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723632     History of Changes
Other Study ID Numbers: P04588
Study First Received: July 25, 2008
Results First Received: November 11, 2011
Last Updated: April 28, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee

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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014