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

Purpose

The objective of the study is to evaluate the costs associated with PegIntron plus 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 HCV therapy-related costs with ribavirin dosing and patient history.

Condition	Intervention
Hepatitis C, Chronic Hepatitis C	Biological: PegIntron (peginterferon alfa-2b; peginterferon α-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908)

MedlinePlus related topics:

Hepatitis Hepatitis C

Drug Information available for:

Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Cost effectiveness: for each weight category, average treatment cost per one patient with sustained virologic response will be evaluated [ Time Frame: Measured throughout the total duration of treatment. Treatment duration is in accordance with approved labeling. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cost effectiveness by subgroups: (1) stratified by ribavirin dosage; and (2) stratified by prior treatment status (ie, treatment-naïve vs relapse patients) [ Time Frame: Measured throughout the total duration of treatment. Treatment duration is in accordance with approved labeling. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

Assigned Interventions

Arm 1

All patients included in the study

Biological: PegIntron (peginterferon alfa-2b; peginterferon α-2b; SCH 54031)

PegIntron administered in accordance with approved labeling, ie, 1.5 μg/kg weekly SC for 48 weeks for patients with HCV genotype 1 or for 24 weeks for patients with HCV genotype 2, 3.

Drug: Rebetol (ribavirin; SCH 18908)

Rebetol administered in accordance with approved labeling, ie, 800 mg/day for patients <65 kg, 1000 mg/day for patients >65 to <85 kg, and 1200 mg/day for patients >=85 kg, administered orally for 48 weeks for patients with HCV genotype 1 or for 24 weeks for patients with HCV genotype 2, 3.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with chronic hepatitis C treated with PegIntron and Rebetol at approximately 81 sites in the Czech Republic.

Criteria

Inclusion Criteria:

Patients 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723632

Contacts


Contact: SP Clinical Trial Registry Call Center	1-888-772-8734

Locations


Czech Republic
	Coordinating Location	Recruiting
	Prague, Czech Republic

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04588
First Received:	July 25, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00723632
Health Authority:	Czech Republic: State Institute for Drug Control; Czech Republic: Ethics Committee

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Ribavirin

Peginterferon alfa-2b

Hepatitis, Viral, Human

Hepatitis C

Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723632