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

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725842
First received: July 28, 2008
Last updated: October 22, 2013
Last verified: October 2013

July 28, 2008
October 22, 2013
January 2009
June 2011   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Relapse rate defined as percentage of patients with undetectable HCV-RNA at the end of the treatment period and detectable HCV-RNA at 6 months post-treatment. [ Time Frame: Relapse is assessed at the end of treatment and 6 months (24 weeks) post-treatment. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00725842 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response [ Time Frame: Baseline and 24 weeks post EOT ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment [ Time Frame: 72 weeks post EOT ] [ Designated as safety issue: No ]
    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.
  • Viral kinetics (Rapid Virologic Response [RVR], Early Virologic Response [EVR], and slow responders) and their influence on the relapse rate [ Time Frame: RVR measured at week 4 of treatment; EVR measured at week 12 of treatment; slow response measured between week 12 and the end of treatment. Relapse measured at 24 weeks post-treatment. ] [ Designated as safety issue: No ]
  • Pre-treatment factors (baseline viral load, genotype 1a vs. 1b, histology, compliance, gender, age, substance abuse, etc.) and their ability to predict relapse [ Time Frame: 4 weeks after the end of previous treatment. Relapse is assessed at 24 weeks (6 months) post-treatment. ] [ Designated as safety issue: No ]
  • "Late" relapse rate assessed in patients with sustained viral response (SVR). "Late relapse" rate is defined as the percentage of patients with relapse at 72 weeks post-treatment. [ Time Frame: As per routine practice, 24 weeks post-treatment, and 72 weeks post-treatment. ] [ Designated as safety issue: No ]
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Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Hepatitis C
  • Hepatitis C, Chronic
  • Biological: Peg-IFN alfa-2b
    Peg-IFN alfa-2b administered in accordance with approved labeling
    Other Name: SCH 054031
  • Drug: Ribavirin
    Ribavirin administered in accordance with approved labeling
    Other Name: SCH 018908
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).
Interventions:
  • Biological: Peg-IFN alfa-2b
  • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
97
June 2011
June 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00725842
P05484
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP