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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00705107
• Other study ID #: P04247
• Status: Terminated
• Phase: N/A
• First received: June 23, 2008
• Last updated: June 3, 2015
• Start date: November 2004
• Est. completion date: November 2007

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 267
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Treatment-naïve patients with hepatitis C

• Patients treated with PegIntron pen and Rebetol

• Patients receiving patient assistance program

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Completed Treatment.		Assessed at the end of the 48-week treatment.	No
Secondary	Average Length of Treatment.		Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.	No