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This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Alfa-2a | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180 micrograms sc weekly for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL | This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported. | Week 96 |
| Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL | This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported. | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelyabinsk | 454052 | Russia | ||||
Out of 20 participants, 18 were included in the study. (4 were Hepatitis B Early Antigen [HBeAg] positive and 14 were HBeAg-negative).
The study was conducted at 7 centers in Russia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a | Eligible participants were administered peginterferon alfa-2a [Pegasys], 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 96 |
| Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants. | Week 96 |
| Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported. | Up to Week 96 |
| Mean Change in Laboratory Parameters (ALT Levels) | Mean Change in Laboratory parameters (ALT levels) is reported. | From Screening (Day 0) to Week 96 |
| Irkutsk |
| 664047 |
| Russia |
| Kazan' | 420097 | Russia |
| Krasnoyarsk | 660049 | Russia |
| Moscow | 111020 | Russia |
| Moscow | 115516 | Russia |
| Moscow | 121293 | Russia |
| Moscow | 123367 | Russia |
| Moscow | Russia |
| Nizhny Novgorod | 603022 | Russia |
| Novokuznetsk | 654063 | Russia |
| Novosibirsk | 630016 | Russia |
| Rostov-on-Don | 344010 | Russia |
| Saint Petersburg | 190103 | Russia |
| Samara | 443021 | Russia |
| Stavropol | 355017 | Russia |
| Tomsk | 634050 | Russia |
| Tyumen | 625002 | Russia |
| Ufa | 450000 | Russia |
| Volgograd | 400138 | Russia |
| Yakutsk | 677000 | Russia |
| Yekaterinburg | 620020 | Russia |
| Yekaterinburg | 620102 | Russia |
| COMPLETED |
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| NOT COMPLETED |
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All participants who received at least one dose of the study drug were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a | Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Hepatitis B Early Antigen (HBeAg) positive participants | Number | participants |
| ||||||||||||||||||||
| HBeAg-negative participants | Count of Participants | Participants |
|
| 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 HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL | This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported. | All participants who received at least one dose of the study drug were considered for analysis. | Posted | Number | Participants | Week 96 |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL | This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported. | All participants who received at least one dose of the study drug were considered for analysis. | Posted | Number | Participants | Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants. | All participants who received at least one dose of the study drug were considered for analysis. | Posted | Number | Participants | Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants. | All participants who received at least one dose of the study drug were considered for analysis. | Posted | Number | Participants | Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported. | Safety population included all participants who received at least one dose of the study drug. | Posted | Number | Participants | Up to Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Change in Laboratory Parameters (ALT Levels) | Mean Change in Laboratory parameters (ALT levels) is reported. | Safety population included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | From Screening (Day 0) to Week 96 |
|
|
Up to Week 96
Safety population included all participants who received at least one dose of the study drug.
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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 | Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks. | 0 | 18 | 3 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| 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 |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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