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Low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-IFN alfa-2b | Biological | Peg-IFN alfa-2b administered in accordance with approved labeling |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hepatitis C previously treated with Peg-IFN alfa-2b + ribavirin in common clinical practice at approximately 60 centers in France.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ribavirin | Drug | Ribavirin administered in accordance with approved labeling |
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| 24 weeks post EOT |
| 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 |
| 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 |
| Participants Eligible for Analysis |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data unavailable for the 7 participants excluded from analysis. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Gender data unavailable for the 7 participants excluded from analysis. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT. | Posted | Number | participants | 24 weeks post end of treatment (EOT) |
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| 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. | The planned analysis for this outcome measure was not performed due to insufficient enrollment. | Posted | 24 weeks post EOT |
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| 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. | The planned analysis for this outcome measure was not performed due to insufficient enrollment. | Posted | Baseline and 24 weeks post EOT |
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| 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. | 77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT. | Posted | Number | participants | 72 weeks post EOT |
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The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 5 | 96 | 21 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthyroidism | Endocrine disorders | MedDRA (9.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (9.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (9.1) | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Hemiplegia | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (9.1) | Systematic Assessment |
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Due to low enrollment some planned analyses were not performed.
Study data disclosure is prohibited; data and study results are the exclusive property of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp & Dohme | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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