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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00728494
First received: July 31, 2008
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Hepatitis C, Chronic
Hepatitis C
 Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
Drug: Rebetol (ribavirin; SCH 18908)
Behavioral: Patient Assistance Program

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program

  • The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment [ Time Frame: Measured at 6 months post-treatment ] [ Designated as safety issue: No ]
    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

  • The Number of Participants Who Relapsed at 6 Months Post-treatment [ Time Frame: Measured at end of treatment and 6 months post-treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Average Length of Treatment [ Time Frame: Maximum 48-week treatment duration ] [ Designated as safety issue: No ]
    Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.

  • Average Dosage of PegIntron [ Time Frame: Up to 48-week treatment duration ] [ Designated as safety issue: No ]
    Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of patient's body weight per week

  • Average Dosage of Rebetol [ Time Frame: Up to 48-week treatment duration ] [ Designated as safety issue: No ]
    Rebetol dosage was expressed in miligrams per kilogram of body weight per day.


Enrollment: 99
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: PegIntron
Drug: Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Other Name: 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 Name: 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 Name: PegIntron
Drug: Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Other Name: Rebetol

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic HCV.

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00728494     History of Changes
Other Study ID Numbers: P04671
Study First Received: July 31, 2008
Results First Received: December 5, 2008
Last Updated: May 1, 2013
Health Authority: Poland: Komisja Bioetyczna

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013