Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705107

Purpose

Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).

Condition	Intervention
Hepatitis C, Chronic Hepatitis C	Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908)

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:	Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Proportion of subjects who completed treatment [ Time Frame: Assessed at Treatment Weeks 12, 24, 36, and 48. Treatment duration is in accordance with approved labeling. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average length of treatment [ Time Frame: Assessed at Treatment Weeks 12, 24, 36, and 48. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	350
Study Start Date:	November 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1 All patients participating in the study	Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031) PegIntron administered in accordance with approved labeling. Drug: Rebetol (ribavirin; SCH 18908) Rebetol administered in accordance with approved labeling

Eligibility

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

Study Population

Treatment-naïve adult patients with hepatitis C treated with PegIntron pen and Rebetol receiving a patient assistance program at approximately 40 sites in Romania. Patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).

Criteria

Inclusion Criteria:

Treatment-naïve patients with hepatitis C
Patients treated with PegIntron pen and Rebetol
Patients receiving patient assistance program

Exclusion Criteria:

Not applicable

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04247
Study First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00705107
Health Authority:	Romania: National Medicines Agency

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Ribavirin
Peginterferon alfa-2b
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009