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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704964
First received: June 23, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention
Hepatitis C
Chronic Hepatitis C
Biological: PegIntron
Drug: Rebetol

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Adherence was based on physiciant's clinical judgment.


Enrollment: 746
Study Start Date: May 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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).

  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704964     History of Changes
Other Study ID Numbers: P04413
Study First Received: June 23, 2008
Results First Received: March 24, 2011
Last Updated: May 21, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014