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

NCT00725842 | Terminated Results

• 1 other identifier: P05484
• Study Type: observational
• Target: 97
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C; Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment

  24 weeks post EOT

• Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response

  Baseline and 24 weeks post EOT

• Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment

  72 weeks post EOT

Study Arms (1)

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).

Biological: Peg-IFN alfa-2b; Drug: Ribavirin

Interventions

Peg-IFN alfa-2b BIOLOGICAL

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

Also known as: SCH 054031

Peg-IFN alfa-2b + ribavirin

Ribavirin DRUG

Ribavirin administered in accordance with approved labeling

Also known as: SCH 018908

Peg-IFN alfa-2b + ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Due to low enrollment some planned analyses were not performed.

Results Point of Contact

• Title: Senior Vice President,Global Clinical Development
• Organization: Merck Sharp & Dohme

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 31, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 21, 2015
• Results First Posted: August 7, 2012

Record last verified: 2015-09