Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)

NCT ID: NCT00705263

Last Updated: 2009-08-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-05-31

Brief Summary

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The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.

Detailed Description

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Conditions

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Hepatitis C, Chronic Hepacivirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic hepatitis C

Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.

Peginterferon alfa-2b (SCH 54031)

Intervention Type BIOLOGICAL

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Ribavirin (SCH 18908)

Intervention Type DRUG

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Interventions

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Peginterferon alfa-2b (SCH 54031)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Intervention Type BIOLOGICAL

Ribavirin (SCH 18908)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Intervention Type DRUG

Other Intervention Names

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PegIntron, PegPen Rebetol

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol

Exclusion Criteria

* Not willing to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role lead

Responsible Party

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Schering-Plough

Other Identifiers

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P04244

Identifier Type: -

Identifier Source: org_study_id

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