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Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)

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ClinicalTrials.gov Identifier: NCT00705107
Recruitment Status : Terminated
First Posted : June 25, 2008
Results First Posted : June 2, 2009
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).

Condition or disease Intervention/treatment
Hepatitis C, Chronic Hepatitis C Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908)

Study Design

Study Type : Observational
Actual Enrollment : 267 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C
Study Start Date : November 2004
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
All Treated Patients
All patients participating in the study
Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling.
Other Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling
Other Name: SCH 18908


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects Who Completed Treatment. [ Time Frame: Assessed at the end of the 48-week treatment. ]

Secondary Outcome Measures :
  1. Average Length of Treatment. [ Time Frame: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Treatment-naïve adult patients with hepatitis C treated with PegIntron pen and Rebetol receiving a patient assistance program at approximately 40 sites in Romania. Patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Criteria

Inclusion Criteria:

  • Treatment-naïve patients with hepatitis C
  • Patients treated with PegIntron pen and Rebetol
  • Patients receiving patient assistance program

Exclusion Criteria:

More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705107     History of Changes
Other Study ID Numbers: P04247
First Posted: June 25, 2008    Key Record Dates
Results First Posted: June 2, 2009
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
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