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Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00704522
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : May 17, 2010
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Hepacivirus Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908) Behavioral: Patient assistance program

Study Design
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Study Type : Observational
Actual Enrollment : 601 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program.
Study Start Date : March 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
 Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Other Name: PegIntron, PegIntron pen

Drug: Ribavirin (SCH 18908)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Other Name: Rebetol

Behavioral: Patient assistance program

Assistance programs will be classified as follows:

  1. Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications)
  2. Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).

In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program [ Time Frame: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up ]
  2. Average Length of Treatment With PegIntron/Rebetol [ Time Frame: After start of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
Criteria

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' labeling (refer to Warnings, contraindications, and safety sections).
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704522    
Other Study ID Numbers: P04281
First Posted: June 25, 2008    Key Record Dates
Results First Posted: May 17, 2010
Last Update Posted: October 6, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents