| Primary | Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment | SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 24 weeks after the end of treatment (72 weeks) | | | | ID | Title | Description |
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| OG000 | Peginterferon Alpha-2a + Ribavirin | Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00083.3(65.28 to 94.36)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used. | 0.8333 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | |
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| Primary | Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR | Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR. | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Participants With SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. | | OG001 | Participants Without SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. |
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| Secondary | Number of Participants With Decrease in Hemoglobin | The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR. | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Participants With SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. | | OG001 | Participants Without SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. |
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| Secondary | Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR | The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR. | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | g/L | | Week 12 | | | | ID | Title | Description |
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| OG000 | Participants With SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. | | OG001 | Participants Without SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. |
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| Secondary | Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR | | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Participants With SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. | | OG001 | Participants Without SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. |
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| Secondary | Number of Participants With Neutropenia Among Participants With or Without SVR | | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Participants With SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. | | OG001 | Participants Without SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. |
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| Secondary | Number of Participants With Thrombocytopenia Among Participants With or Without SVR | | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Participants With SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. | | OG001 | Participants Without SVR | Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. |
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