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An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN) (PEGIMPACT)

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ClinicalTrials.gov Identifier: NCT00704756
Recruitment Status : Withdrawn
First Posted : June 25, 2008
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. The objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).

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

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Official Title: An Observational Multi-Center Study Exploring the Association of Safety, Patient Characteristics, Virological, and Histological Parameters With Patient Outcome (Relapse Rate, Achievement of Sustained Viral Response in Daily Clinical Practice in Belgium- PEGIMPACT
Study Start Date : January 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Arm 1
Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered at 1.5 μg/kg body weight/week subcutaneously for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)
Other Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered based on body weight 800-1200 mg/day (<65 kg : 800 mg, 65 - 85 kg : 1000 mg, >85 kg : 1200 mg) orally for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)
Other Name: SCH 18908


Outcome Measures

Primary Outcome Measures :
  1. Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications [ Time Frame: Assessed retrospectively in patients treated for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) and reaching End-of-Treatment. ]

Secondary Outcome Measures :
  1. Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters [ Time Frame: Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment ]
  2. Predictors of response at End-of-Treatment [ Time Frame: Assessed at the End-of-Treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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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 with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Criteria

Inclusion Criteria:

  • Male and female adult (18 years or older) subjects for whom the treating physician has decided to start treatment with PegIntron® and Rebetol® and reaching the End-of-Treatment time point.
  • For the prospective component, evidence of treatment response at EOT after a complete course of therapy as per SmPC.
  • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Subjects must be diagnosed with chronic hepatitis C (genotypes 1, 2, 3, 4, 5 or 6).
  • Subjects must be free of any clinically significant disease that would interfere with study participation.

Exclusion Criteria:

  • For prospective component of the study: patients not achieving End-of-Treatment response after a complete course of therapy as per SmPC.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704756     History of Changes
Other Study ID Numbers: P05494
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

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