Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)

NCT ID: NCT00704964

Last Updated: 2015-10-06

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

746 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-10-31

Brief Summary

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The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management.

The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.

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 participants

Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.

PegIntron

Intervention Type BIOLOGICAL

PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany

Rebetol

Intervention Type DRUG

Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany

Interventions

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PegIntron

PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany

Intervention Type BIOLOGICAL

Rebetol

Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany

Intervention Type DRUG

Other Intervention Names

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PegIntron pen peginterferon alfa-2b SCH 54031 ribavirin SCH 18908

Eligibility Criteria

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Inclusion Criteria

* Participants with chronic hepatitis C.

Those participating in patient assistance programs during therapy for hepatitis C.

Exclusion Criteria

* Participants who have previously been treatment for hepatitis C (non-naïve)
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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P04413

Identifier Type: -

Identifier Source: org_study_id

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