Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413) (@dhere)
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|ClinicalTrials.gov Identifier: NCT00704964|
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : April 21, 2011
Last Update Posted : October 6, 2015
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.
|Condition or disease||Intervention/treatment|
|Hepatitis C Chronic Hepatitis C||Biological: PegIntron Drug: Rebetol|
|Study Type :||Observational|
|Actual Enrollment :||746 participants|
|Official Title:||Impact of Patient Support From Medical Staff on the Adherence to Therapy With PegIntron Plus Rebetol|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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 (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany
Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany
- Number of Participants With Biometrical Adherence to Therapy [ Time Frame: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 ]Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.
- Number of Participants With Adherence to Therapy According to Physician Approximation [ Time Frame: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 ]Adherence was based on physiciant's clinical judgment.