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

Sponsor:	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)

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A 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:

Number of Subjects Who Completed Treatment. [ Time Frame: Assessed at the end of the 48-week treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average Length of Treatment. [ Time Frame: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks. ] [ Designated as safety issue: No ]

Enrollment:	267
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
All Treated Patients All patients participating in the study	Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031) PegIntron administered in accordance with approved labeling. Other Name: SCH 54031 Drug: Rebetol (ribavirin; SCH 18908) Rebetol administered in accordance with approved labeling Other Name: SCH 18908

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

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705107 History of Changes
Other Study ID Numbers:	P04247
Study First Received:	June 23, 2008
Results First Received:	February 11, 2009
Last Updated:	March 11, 2011
Health Authority:	Romania: National Medicines Agency

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

Hepatitis, Chronic
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 February 09, 2012