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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
Sponsor:
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

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

MedlinePlus related topics: Hepatitis C
U.S. FDA Resources

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.



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Ages Eligible for Study:   Child, Adult, Senior
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.
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).


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704964     History of Changes
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:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs