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In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a + Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Peginterferon alfa-2a according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment). | 6 months after the last study drug administration (up to 123.6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Undetectable HCV RNA | Undetectable HCV RNA=a single last HCV RNA <20 IU/mL | Weeks 4, 12 and at end of treatment (up to 99.6 weeks) |
| HCV RNA Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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Slovenian patients with chronic hepatitis C (CHC) treated with Peginterferon alfa-2a and ribavirin.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celje | 3000 | Slovenia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a + Ribavirin | Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated participants were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a + Ribavirin | Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment | SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment). | All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment). | Posted | Number | percentage of participants | 6 months after the last study drug administration (up to 123.6 weeks) |
|
From signature of informed consent to end of treatment (up to 99.6 weeks)
All treated participants were included.
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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 | Peginterferon Alfa-2a + Ribavirin | Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leucopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800 821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Ribavirin | Drug | Ribavirin according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling. |
|
|
| Thrombocyte Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
| Leukocyte Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
| Hemoglobin Values | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
| Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin | Up to 99.6 Weeks |
| Ljubljana |
| 1000 |
| Slovenia |
| Maribor | 2000 | Slovenia |
| Novo Mesto | 8000 | Slovenia |
| Enrolled but not treated |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
|
|
| Secondary | Percentage of Participants With Undetectable HCV RNA | Undetectable HCV RNA=a single last HCV RNA <20 IU/mL | All treated participants were included in the analysis. | Posted | Number | percentage of participants | Weeks 4, 12 and at end of treatment (up to 99.6 weeks) |
|
|
|
| Secondary | HCV RNA Values | Number of participants analyzed=treated participants with data available for HCV RNA. Here, "n" specifies number of participants with data available for specified category. | Posted | Mean | Standard Deviation | IU/mL | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
|
|
|
| Secondary | Thrombocyte Values | Number of participants analyzed=treated participants with data available for thrombocyte value. Here, "n" specifies number of participants with data available for specified category. | Posted | Mean | Standard Deviation | billion cells per liter | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
|
|
|
| Secondary | Leukocyte Values | Number of participants analyzed=treated participants with data available for leukocyte value. Here, "n" specifies number of participants with data available for specified category. | Posted | Mean | Standard Deviation | billion cells per liter | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
|
|
|
| Secondary | Hemoglobin Values | Number of participants analyzed=treated participants with data available for hemoglobin. Here, "n" specifies number of participants with data available for specified category. | Posted | Mean | Standard Deviation | gram per liter | Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks) |
|
|
|
| Secondary | Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin | All treated participants were included. | Posted | Mean | Standard Deviation | weeks | Up to 99.6 Weeks |
|
|
|
| 4 |
| 268 |
| 15 |
| 268 |
| Sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Depressive disorder | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Sudden death NOS | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title |
|---|
| Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| End of treatment (n=224) |
|
| 6 months post treatment (n=195) |
|
| Title | Measurements |
|---|---|
|
| End of treatment (n=224) |
|
| 6 months post treatment (n=198) |
|
| Title | Measurements |
|---|---|
|
| End of treatment (n=224) |
|
| 6 months post treatment (n=198) |
|
| Title | Measurements |
|---|---|
|
| End of treatment (n=224) |
|
| 6 months post treatment (n=198) |
|