Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed) (RE-CHUT)

September 18, 2015 updated by: Merck Sharp & Dohme LLC

Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice

The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be completed prior to the enrollment in the current study. The study will also aim to identify factors that are predictive of relapse. Relapse rate is defined as the percentage of patients with negative viral load at end of treatment who again have positive viral load at 6 months after the end of treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Non-probability sampling: The study population consists of adult patients over the age of 18 affected by CHC who were previously treated for the first time with Peg-IFN alfa-2b plus ribavirin and achieved end-of-treatment response. Five hundred ninety patients must be recruited in order to evaluate the objectives of the study. The patients must meet all inclusion criteria and not meet any of the exclusion criteria in order to be included in the study.

Study Type

Observational

Enrollment (Actual)

97

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatitis C previously treated with Peg-IFN alfa-2b + ribavirin in common clinical practice at approximately 60 centers in France.

Description

Inclusion Criteria:

  • The patient must demonstrate his/her continued willingness to participate in the study.
  • The patient must be at least 18 years of age, of either gender.
  • Patients with chronic hepatitis C (any genotype) who received Peg-IFN alfa-2b + Ribavirin as first treatment for hepatitis C.
  • Negative HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.

Exclusion Criteria:

  • Patients who completed treatment with PegInterferon Alfa-2b plus Ribavirin more than 4 weeks before study entry.
  • Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
  • Patients treated for a period shorter than the enrollment period.
  • Patients co-infected with human immunodeficiency virus (HIV).
  • Patients co-infected with hepatitis B virus (HBV).
  • Patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peg-IFN alfa-2b + ribavirin
Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Drug: Ribavirin
Ribavirin administered in accordance with approved labeling
Other Names:
  • SCH 018908
Biological: Peg-IFN alfa-2b
Peg-IFN alfa-2b administered in accordance with approved labeling
Other Names:
  • SCH 054031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
Time Frame: 24 weeks post end of treatment (EOT)
HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.
24 weeks post end of treatment (EOT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment
Time Frame: 24 weeks post EOT
Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.
24 weeks post EOT
Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response
Time Frame: Baseline and 24 weeks post EOT
Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.
Baseline and 24 weeks post EOT
Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment
Time Frame: 72 weeks post EOT
HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.
72 weeks post EOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 31, 2008

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05484

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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