N/A N=746

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

Hepatitis C · Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT00704964 ↗

Enrolled (actual)

746

Serious AEs

3.6%

Results posted

Apr 2011

Primary outcome: Primary: Number of Participants With Biometrical Adherence to Therapy — 406; 415; 413 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: PegIntron (Biological); Rebetol (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Biometrical Adherence to Therapy	406; 415; 413	—
PRIMARY Number of Participants With Adherence to Therapy According to Physician Approximation	615; 604	—

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.

Eligibility Criteria

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)

Other exclusion criteria as described in local Summary of Product Characteristics (SPC).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00704964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.