Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)

NCT00704964 | Completed Results

• 1 other identifier: P04413
• Study Type: observational
• Target: 746
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management. The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.

Conditions

Hepatitis C; Chronic Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Biometrical Adherence to Therapy

  Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.

  Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3

• Number of Participants With Adherence to Therapy According to Physician Approximation

  Adherence was based on physiciant's clinical judgment.

  Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3

Study Arms (1)

All participants

Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.

Biological: PegIntron; Drug: Rebetol

Interventions

PegIntron BIOLOGICAL

PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany

Also known as: PegIntron pen, peginterferon alfa-2b, SCH 54031

All participants

Rebetol DRUG

Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany

Also known as: ribavirin, SCH 18908

All participants

Eligibility Criteria

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

Study Population

Participants with chronic hepatitis C treated in 44 non-university centers in Germany.

You may qualify if:

• Participants with chronic hepatitis C.
• Those participating in patient assistance programs during therapy for hepatitis C.

You may not qualify if:

• Participants who have previously been treatment for hepatitis C (non-naïve)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; 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: May 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 6, 2015
• Results First Posted: April 21, 2011

Record last verified: 2015-10