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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705107
First received: June 23, 2008
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Subjects Who Completed Treatment. [ Time Frame: Assessed at the end of the 48-week treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Length of Treatment. [ Time Frame: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks. ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: November 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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:

  • Not applicable
  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: NCT00705107     History of Changes
Other Study ID Numbers: P04247
Study First Received: June 23, 2008
Results First Received: February 11, 2009
Last Updated: May 6, 2014
Health Authority: Romania: National Medicines Agency

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
Peginterferon alfa-2b
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014