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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00725842
First received: July 28, 2008
Last updated: June 25, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hepatitis C Hepatitis C, Chronic |
Biological: Peg-IFN alfa-2b Drug: Ribavirin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice |
Resource links provided by NLM:
Drug Information available for:
Ribavirin
Interferon Alfa-2a
Interferon Alfa-2b
Peginterferon Alfa-2b
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 97 |
| Study Start Date: | January 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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).
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00725842 History of Changes |
| Other Study ID Numbers: | P05484 |
| Study First Received: | July 28, 2008 |
| Results First Received: | June 13, 2012 |
| Last Updated: | June 25, 2012 |
| Health Authority: | France: Physicians National Council |
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 Interferon Alfa-2a Interferon-alpha |
Interferon Alfa-2b Ribavirin Peginterferon alfa-2b Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013