Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00723879

Enrollment

115

Registered

2008-07-29

Start date

2004-10-31

Completion date

2008-07-31

Last updated

2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepacivirus, Hepatitis C, Chronic

Brief summary

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. 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.

Interventions

BIOLOGICALPeginterferon alfa-2b (SCH 54031)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

DRUGRibavirin (SCH 18908)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

BEHAVIORALPatient assistance program

Patient assistance programs will be classified as follows: 1. medications, including psychiatric medications (antidepressants); 2. other interventions, including nurse telephone calls and nurse support in the office: and 3. educational literature about hepatitis C containing information about the disease, mode of transmission, complications, and treatment and treatment drawbacks that will be given to each patient at the start of treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with chronic hepatitis C naive to treatment

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program.	NA (i.e. the study was terminated)
Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol.	NA (i.e. the study was terminated)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026