Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)

NCT00705263 | Completed Results

• 1 other identifier: P04244
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.

Conditions

Hepatitis C, Chronic; Hepacivirus

Outcome Measures

Primary Outcomes (1)

• Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.

  Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.

  After 4 weeks of treatment.

Study Arms (1)

Patients with chronic hepatitis C

Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.

Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

Interventions

Peginterferon alfa-2b (SCH 54031) BIOLOGICAL

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

Also known as: PegIntron, PegPen

Patients with chronic hepatitis C

Ribavirin (SCH 18908) DRUG

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

Also known as: Rebetol

Patients with chronic hepatitis C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol at sites in Slovenia.

You may qualify if:

• Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol

You may not qualify if:

• Not willing to participate in the study

Sponsors & Collaborators

• Schering-Plough: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Head, Clinical Trials Registry & Results Disclosure Group
• Organization: Schering-Plough

ClinicalTrialsDisclosure@spcorp.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 26, 2008
• Study Start: October 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 25, 2009
• Results First Posted: July 17, 2009

Record last verified: 2009-08