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

This study has been 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) )

Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00723879
  Purpose

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

MedlinePlus related topics:   Hepatitis    Hepatitis C   

Drug Information available for:   Ribavirin    Peginterferon Alfa-2b   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   115
Study Start Date:   October 2004
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
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.
Drug: Ribavirin (SCH 18908)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations

No Contacts or Locations Provided
  More Information


Responsible Party:   Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:   P04206
First Received:   July 25, 2008
Last Updated:   July 25, 2008
ClinicalTrials.gov Identifier:   NCT00723879
Health Authority:   Saudi Arabia: College of Medicine Research Center (CMRC)

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis
Body Weight
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 24, 2008

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