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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704522
First received: June 23, 2008
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Average Length of Treatment With PegIntron/Rebetol [ Time Frame: After start of treatment ] [ Designated as safety issue: No ]

Enrollment: 601
Study Start Date: March 2005
Study Completion Date: April 2009
Primary Completion Date: April 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 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.


  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704522     History of Changes
Other Study ID Numbers: P04281
Study First Received: June 23, 2008
Results First Received: April 21, 2010
Last Updated: April 28, 2014
Health Authority: Austria: Not Required

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 July 22, 2014