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

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

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.

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

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04588
Study First Received:	July 25, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00723632 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control; Czech Republic: Ethics Committee

Study placed in the following topic categories:

Antimetabolites
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Ribavirin
Peginterferon alfa-2b
Hepatitis, Viral, Human
Hepatitis C
Antiviral Agents
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Flaviviridae Infections
Ribavirin
Hepatitis, Viral, Human

Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Peginterferon alfa-2b
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 07, 2009