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Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)

NCT ID: NCT00704717

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

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-12-31

Brief Summary

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The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.

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Detailed Description

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Conditions

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Hepatitis C, Chronic Hepatitis C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All Treated Patients

All patients participating in the study.

PegIntron (peginterferon alfa-2b; SCH 54031) pen

Intervention Type BIOLOGICAL

PegIntron pen administered in accordance with approved labeling

Rebetol (ribavirin; SCH 18908)

Intervention Type DRUG

Rebetol administered in accordance with approved labeling.

Interventions

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PegIntron (peginterferon alfa-2b; SCH 54031) pen

PegIntron pen administered in accordance with approved labeling

Intervention Type BIOLOGICAL

Rebetol (ribavirin; SCH 18908)

Rebetol administered in accordance with approved labeling.

Intervention Type DRUG

Other Intervention Names

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SCH 54031 SCH 18908

Eligibility Criteria

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Inclusion Criteria

* Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania.

Exclusion Criteria

* Not applicable
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

Other Identifiers

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P04301

Identifier Type: -

Identifier Source: org_study_id

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