Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723892

Purpose

Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Condition	Intervention
Hepatitis C, Chronic Hepacivirus	Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908) Behavioral: Psychotherapy support program

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

To evaluate the proportion of patients who complete treatment with PegIntron pen/Rebetol therapy for hepatitis C when administered with a patient psychotherapy support program as compared to a group without a psychotherapy support program. [ Time Frame: D0, M1, M3, M6, for genotype 2 and 3; 2 other visits at M9 and M12 for genotype 1. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the average length of treatment for patients receiving psychotherapy support during the course of their treatment for hepatitis C with PegIntron pen/Rebetol [ Time Frame: D0, M1, M3, M6, for genotype 2 and 3; 2 other visits at M9 and M12 for genotype 1. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	634
Study Start Date:	July 2005
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 PegIntron/Rebetol and psychotherapy support program (Two groups of patients will be enrolled and compared in this study: a group of patients receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program. All patients will receive PegIntron pen and Rebetol according to the labeling.)	Biological: Peginterferon alfa-2b (SCH 54031) Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling. Drug: Ribavirin (SCH 18908) Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling. Behavioral: Psychotherapy support program Each site has implemented a psychotherapy support program.
Group 2 PegIntron/Rebetol	Biological: Peginterferon alfa-2b (SCH 54031) Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling. Drug: Ribavirin (SCH 18908) Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Detailed Description:

Enrollment of patients will occur in a sequential order of treatment initiation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients at sites in France who are receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program.

Criteria

Inclusion Criteria:

Adult patients with hepatitis C

Exclusion Criteria:

According to the products' labeling

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04252
Study First Received:	July 25, 2008
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00723892 History of Changes
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Angiogenesis Inhibitors

Antiviral Agents
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
Liver Diseases
Hepatitis, Chronic
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2b
Interferon Alfa-2b
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on September 11, 2009