| Primary | Percentage of Participants With Sustained Virological Response (SVR) | SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment). | Per Protocol (PP) population included all participants without any protocol violation. | Posted | | Number | | percentage of participants | | 24 weeks after End of treatment (EOT) (up to Week 96) | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Primary | Percentage of Participants With Relapse | Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up. | | Posted | | Number | | percentage of participants | | Up to 24 weeks after EOT (up to Week 96) | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Primary | Percentage of Participants Who Were Non-Responders | Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period. | | Posted | | Number | | percentage of participants | | Up to 24 weeks after EOT (up to Week 96) | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Percentage of Participants With Positive Predictive Value on SVR at Week 4 | Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported. | PP population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure and "n" signified evaluable participants for specific group. | Posted | | Number | | percentage of participants | | Week 4 | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Percentage of Participants With Positive Predictive Value on SVR at Week 12 | Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported. | PP population. Here "number of participants analyzed" included participants evaluable for the outcome measure and "n" signified evaluable participants for specific group. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Correlation of SVR With Rapid Virological Response (RVR) | Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment. | PP population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure. | Posted | | Number | | correlation coefficient | | Up to 24 weeks after EOT (up to Week 96) | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Correlation of SVR With Early Virological Response (EVR) | Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment. | PP population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure. | Posted | | Number | | correlation coefficient | | Up to 24 weeks after EOT (up to Week 96) | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response | Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment. | PP population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure | Posted | | Number | | predictive value | | Week 4 and 12 | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Duration of Treatment in Participants With SVR by HCV Genotype | SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. | PP population. Here "number of participants analyzed" included participants evaluable for the outcome measure and "n" signified evaluable participants for specific HCV genotype. | Posted | | Mean | Full Range | days | | Up to Week 72 | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype | SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. | PP population. Here "number of participants analyzed" included participants evaluable for the outcome measure and "n" signified evaluable participants for specific HCV genotype. | Posted | | Mean | Full Range | µg | | Up to Week 72 | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype | SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. | PP population. Here "number of participants analyzed" included participants evaluable for the outcome measure and "n" signified evaluable participants for specific HCV genotype. | Posted | | Mean | Full Range | mg | | Up to Week 72 | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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| Secondary | Percentage of Participants With Virological Response | The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse. | | Posted | | Number | | percentage of participants | | 4 weeks after EOT (up to Week 76) | | | | ID | Title | Description |
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| OG000 | HCV Infected Participants | Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators' discretion. |
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