Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)

NCT00704717 | Completed Results

• 1 other identifier: P04301
• Study Type: observational
• Target: 185
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.

Conditions

Hepatitis C, Chronic; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.

  The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.

  The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.

Study Arms (1)

All Treated Patients

All patients participating in the study.

Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen; Drug: Rebetol (ribavirin; SCH 18908)

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) pen BIOLOGICAL

PegIntron pen administered in accordance with approved labeling

Also known as: SCH 54031

All Treated Patients

Rebetol (ribavirin; SCH 18908) DRUG

Rebetol administered in accordance with approved labeling.

Also known as: SCH 18908

All Treated Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hepatitis C under treatment with PegIntron Pen plus Rebetol therapy at approximately 70 sites in Romania.

You may qualify if:

• Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; penclomedine; Ribavirin

Condition Hierarchy (Ancestors)

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: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: September 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 29, 2015
• Results First Posted: June 2, 2009

Record last verified: 2015-04