| Primary | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. | | OG003 | Peginterferon Alfa-2a 180 μg_48 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
| | Units | Counts |
|---|
| Participants | - OG000142
- OG001140
- OG002132
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00014.08(8.82 to 20.91)
- OG00122.86(16.19 to 30.71)
- OG00225.76(18.54 to 34.09)
- OG003
|
|
| |
| Secondary | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. | |
|
| Secondary | Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
|
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
|
| Secondary | Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
|
| Secondary | Percentage of Participants With Normal Alanine Aminotransferase (ALT) | Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
|
| Secondary | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of < 20,000 IU/mL (Less than 100,000 copies/mL) is reported. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks |
|
| Secondary | Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of < 2,000 IU/mL (Less than 10,000 copies/mL) is reported. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | |
|
| Secondary | Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL. | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. | |
|
| Secondary | Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA <2,000 IU/ml (Less than 10,000 copies/mL). | Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
|
| Secondary | Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment | Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L). | Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Mean | 95% Confidence Interval | U/L | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
|
| Secondary | Quantitative HBV-DNA 24 Weeks Following End of Treatment | Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. | Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis. | Posted | | Mean | 95% Confidence Interval | IU/mL Log10 | | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | | | | ID | Title | Description |
|---|
| OG000 | Peginterferon Alfa-2a 90 μg_24 Weeks | Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG001 | Peginterferon Alfa-2a 180 μg_24 Weeks | Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | | OG002 | Peginterferon Alfa-2a 90 μg_48 Weeks | Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. |
|