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

NCT00704964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 746

Last updated 2015-10-06

Study results available
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Summary

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.

Conditions

  • Hepatitis C
  • Chronic Hepatitis C

Interventions

BIOLOGICAL

PegIntron

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

DRUG

Rebetol

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

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704964 on ClinicalTrials.gov