Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704522

Purpose

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

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

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

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 Patient Assistance Program.

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 assistance program and to evaluate the average length of treatment with PegIntron/Rebetol. [ Time Frame: 24 (genotype 2 and 3) or 48 weeks (genotype 1 and 4) and 24 weeks of follow up ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	601
Study Start Date:	March 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with hepatitis C Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.	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: Patient assistance program Assistance programs will be classified as follows: Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.

Groups/Cohorts

Assigned Interventions

Patients with hepatitis C

Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.

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: Patient assistance program

Assistance programs will be classified as follows:

Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications)
Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).

In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.

Eligibility

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

Study Population

Adult patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.

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

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04281
Study First Received:	June 23, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00704522
Health Authority:	Austria: Not Required

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