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Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

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ClinicalTrials.gov Identifier: NCT00723879
Recruitment Status : Terminated (Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients))
First Posted : July 29, 2008
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. 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 Type : Observational
Actual Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.
Study Start Date : October 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program.
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Other Name: PegIntron
Drug: Ribavirin (SCH 18908)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Other Name: Rebetol
Behavioral: Patient assistance program

Patient assistance programs will be classified as follows:

  1. medications, including psychiatric medications (antidepressants);
  2. other interventions, including nurse telephone calls and nurse support in the office: and
  3. educational literature about hepatitis C containing information about the disease, mode of transmission, complications, and treatment and treatment drawbacks that will be given to each patient at the start of treatment.



Primary Outcome Measures :
  1. Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program. [ Time Frame: NA (i.e. the study was terminated) ]
  2. Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol. [ Time Frame: NA (i.e. the study was terminated) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature.
Criteria

Inclusion Criteria:

  • Patients with chronic hepatitis C naive to treatment

Exclusion Criteria:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723879     History of Changes
Other Study ID Numbers: P04206
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs