Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

July 20, 2015 updated by: Merck Sharp & Dohme LLC

Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-Probability Sample, Commercial product used according to EU label.

Study Type

Observational

Enrollment (Actual)

99

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic HCV.

Description

Inclusion Criteria:

  • According to PegIntron/Rebetol label.
  • Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion Criteria:

  • According to PegIntron/Rebetol label.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment and Patient Assistance Program
Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.
Other Names:
  • PegIntron
Drug: Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Other Names:
  • Rebetol
Behavioral: Patient Assistance Program

The patient assistance program includes the following:

  • Training by physicians or specialized nurses.
  • Informational materials based on the "To beat HCV" program.
  • Management of specific side effects.
Other Names:
  • Support program
Treatment Alone
PegIntron/Rebetol treatment only.
Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.
Other Names:
  • PegIntron
Drug: Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Other Names:
  • Rebetol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
Time Frame: At the end of the 48-week treatment period
Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program
At the end of the 48-week treatment period
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
Time Frame: Measured at 6 months post-treatment
Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment
Measured at 6 months post-treatment
The Number of Participants Who Relapsed at 6 Months Post-treatment
Time Frame: Measured at end of treatment and 6 months post-treatment
Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment
Measured at end of treatment and 6 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Length of Treatment
Time Frame: Maximum 48-week treatment duration
Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.
Maximum 48-week treatment duration
Average Dosage of PegIntron
Time Frame: Up to 48-week treatment duration
Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week
Up to 48-week treatment duration
Average Dosage of Rebetol
Time Frame: Up to 48-week treatment duration
Rebetol dosage was expressed in milligrams per kilogram of body weight per day.
Up to 48-week treatment duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04671

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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