Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00704964
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : April 21, 2011
Last Update Posted : October 6, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Chronic Hepatitis C Biological: PegIntron Drug: Rebetol

Layout table for study information
Study Type : Observational
Actual Enrollment : 746 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.
Biological: PegIntron
PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany
Other Names:
  • PegIntron pen
  • peginterferon alfa-2b
  • SCH 54031

Drug: Rebetol
Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany
Other Names:
  • ribavirin
  • SCH 18908

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with chronic hepatitis C treated in 44 non-university centers in Germany.

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).

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00704964    
Other Study ID Numbers: P04413
First Posted: June 25, 2008    Key Record Dates
Results First Posted: April 21, 2011
Last Update Posted: October 6, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs