Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)

NCT ID: NCT00727259

Last Updated: 2015-04-29

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

1995 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-04-30

Brief Summary

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The current gold standard for treatment of chronic hepatitis C (CHC) patients is with 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 PegPen. The goal of this study is to determine the satisfaction grade with this novel device.

Detailed Description

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Enrollment of patients will occur in a sequential order of treatment initiation.

Conditions

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Hepatitis C, Chronic

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

Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.

Peginterferon alfa-2b (SCH 54031)

Intervention Type BIOLOGICAL

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

Ribavirin (SCH 18908)

Intervention Type DRUG

Ribavirin will be administered according to the products' labeling.

Interventions

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Peginterferon alfa-2b (SCH 54031)

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

Intervention Type BIOLOGICAL

Ribavirin (SCH 18908)

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

* Adult patients with hepatitis C

Exclusion Criteria

* According to the products' labeling.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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P04067

Identifier Type: -

Identifier Source: org_study_id

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