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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00723632
Other study ID # P04588
Secondary ID
Status Completed
Phase N/A
First received July 25, 2008
Last updated October 1, 2015
Start date September 2005
Est. completion date December 2010

Study information

Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug ControlCzech Republic: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 901
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participants with chronic hepatitis C

- At least 18 years old

- Eligibility determined based on the diagnosis and medical judgment only.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category 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 No
Secondary Average Cost Per Participant With SVR Stratified by Ribavirin Dosage 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 No
Secondary Average Cost Per Participant With SVR Stratified by Prior Treatment Status 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 No
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