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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704964

Purpose

The objective of this study is to assess the impact of patient care and support on treatment adherence. PegIntron pen and Rebetol will be administered to patients with HCV in accordance with approved labeling. Sites will be categorized as providing high vs low level of patient management based on information about the level of patient support and management captured on the site questionnaire. Data on each patient will be collected by a physician on an electronic patient CRF and by the patient via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of patient management.

The hypothesis is that Physicians investing more time and effort into patient management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less patient management measures.

Condition	Intervention
Hepatitis C Chronic Hepatitis C	Biological: Peginterferon alfa-2b Drug: Ribavirin

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Impact of Support Programs on Treatment Adherence in Patient With Chronical Hepatitis C Treated With PegIntron/Rebetol

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Proportion of patients who complete treatment by high vs low level of patient management [ Time Frame: The timeframe for individual patient will be from the start until the end of treatment (regardless of whether a full course of therapy is completed): up to 48 weeks for HCV genotype 1/4 patients and up to 24 weeks for HCV genotype 2 or 3 patients. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients who complete treatment Average length of treatment [ Time Frame: Up to 48 weeks for HCV genotype 1/4 patients and up to 24 weeks for HCV genotype 2 or 3 patients ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	732
Study Start Date:	May 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
All patients Each site will be evaluated by a site questionnaire and assigned as either a high or low patient management site. Patients are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low patient management sites	Biological: Peginterferon alfa-2b PegIntron pen administered at a dose and frequency in accordance with approved labeling in Germany Drug: Ribavirin Ribavirin administered at a dose and frequency in accordance with approved labeling in Germany

Detailed Description:

Each site will be evaluated by a site questionnaire and assigned as either a high or low patient management site. Patients are not randomized to a group. However, patient's choice of site will determine whether they will be assigned in the analysis to either high vs low patient management group.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with chronic hepatitis C treated in 44 non-university centers in Germany.

Criteria

Inclusion Criteria:

Patients with chronical hepatitis C. Subjects participating in patient assistance programs during therapy for hepatitis C.

Exclusion Criteria:

Patients who have previously been treatment for hepatitis C (non-naïve) Other exclusion criteria as described in local SPC

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04413
Study First Received:	June 23, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00704964
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009