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

Hepatitis C Clinical Trial

— RE-CHUT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00725842
• Other study ID #: P05484
• Status: Terminated
• Phase: N/A
• First received: July 28, 2008
• Last updated: September 18, 2015
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Physicians National Council
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• Peg-IFN alfa-2b
Peg-IFN alfa-2b administered in accordance with approved labeling

Drug:
• Ribavirin
Ribavirin administered in accordance with approved labeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment	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)	No
Secondary	Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment	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	No
Secondary	Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response	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	No
Secondary	Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment	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	No