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This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Alfa-2a | Experimental | Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | 180 mcg subcutaneously once per week for 48 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL) | HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline. | Week 72 |
| Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL | HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline. | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HBV-DNA < 400 Copies/mL | Week 72 | |
| Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants | HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported. |
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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 |
|---|---|---|---|---|---|---|
| Tallinn | 10138 | Estonia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a | Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Week 48 and Week 72 |
| Percentage of Anti-HBs Positive Participants | HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported. | Week 48 and Week 72 |
| Mean Alanine Aminotransferase (ALT) Concentrations | Week 48 and Week 72 |
| Percentage of HBeAg Negative Participants | HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported. | Week 48 and Week 72 |
| Percentage of Anti-HBe Positive Participants | HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported. | Week 48 and Week 72 |
| Tallinn |
| 10617 |
| Estonia |
| Tartu | 51014 | Estonia |
| Riga | 1006 | Latvia |
| Kaunas | 47144 | Lithuania |
| Kaunas | 50009 | Lithuania |
| Klaipėda | 92288 | Lithuania |
| Vilnius | 08117 | Lithuania |
| Vilnius | 08661 | Lithuania |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants who received at least 1 dose of peginterferon alfa-2a.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a | Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL) | HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline. | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline. | Posted | Number | participants | Week 72 |
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| Primary | Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL | HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline. | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline. | Posted | Number | participants | Week 72 |
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| Secondary | Number of Participants With HBV-DNA < 400 Copies/mL | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure. | Posted | Number | participants | Week 72 |
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| Secondary | Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants | HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported. | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 48 and Week 72 |
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| Secondary | Percentage of Anti-HBs Positive Participants | HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported. | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points. | Posted | Number | percentage of participants | Week 48 and Week 72 |
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| Secondary | Mean Alanine Aminotransferase (ALT) Concentrations | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | international units per liter (IU/L) | Week 48 and Week 72 |
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| Secondary | Percentage of HBeAg Negative Participants | HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported. | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points. | Posted | Number | percentage of participants | Week 48 and Week 72 |
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| Secondary | Percentage of Anti-HBe Positive Participants | HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported. | All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points. | Posted | Number | percentage of participants | Week 48 and Week 72 |
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AEs were recorded from Screening till Week 72.
All enrolled participants who received at least 1 dose of peginterferon alfa-2a were included in safety analysis.
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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 | Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks. | 0 | 39 | 15 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Subfebrile temperature | General disorders | MedDRA | Non-systematic Assessment |
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| Weakness | General disorders | MedDRA | Non-systematic Assessment |
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| Headache | General disorders | MedDRA | Non-systematic Assessment |
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| Anxiety | General disorders | MedDRA | Non-systematic Assessment |
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| Heartburn | General disorders | MedDRA | Non-systematic Assessment |
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| Arterial hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Barrett esophagus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Stomach ache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Blood in stool | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Prostate hyperplasia | Gastrointestinal disorders | MedDRA | Non-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 | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.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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| Title | Denominators | Categories | ||||
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| Week 48 |
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| Week 72 |
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