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This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a | Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Biological | Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml). | At the end of the study (Week 36) |
| Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml | approximately 3 years | |
| In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive | approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis B on treatment with PEGASYS.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mhat - Pleven; Clinic of Gastroenterology | Pleven | 5800 | Bulgaria | |||
| Umhat St. Georgi; Clinical of Gastroenterology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a | Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| At the end of treatment (Week 24) |
| HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative | approximately 3 years |
| Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients | approximately 3 years |
| Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients | approximately 3 years |
| Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio | approximately 3 years |
| Safety: Incidence of Adverse Events | approximately 3 years |
| Plovdiv |
| 4002 |
| Bulgaria |
| MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases | Sofia | 1407 | Bulgaria |
| UMHAT Alexandrovska EAD; Gastroenterology | Sofia | 1431 | Bulgaria |
| Mhat Queenjoanna; Clinic of Gastroenterology | Sofia | 1527 | Bulgaria |
| Military Medical Academy; Gastroenterology | Sofia | 1606 | Bulgaria |
| Mhat St. Ivan Rilski; Clinic of Gastroenterology | Sofia | 1612 | Bulgaria |
| Mhat St. Zagora; Clinical of Gastroenterology | Stara Zagora | 6000 | Bulgaria |
| Mhat Sveta Marina; Clinic of Gastroenterology | Varna | 9010 | Bulgaria |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat population: All 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 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml). | Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. | Posted | Number | 95% Confidence Interval | Percentage of participants | At the end of the study (Week 36) |
|
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| Primary | Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml | Not Posted | approximately 3 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative. | Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of treatment (Week 24) |
|
| ||||||||||||||||||||||||||
| Secondary | HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative | Not Posted | approximately 3 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients | Not Posted | approximately 3 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients | Not Posted | approximately 3 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio | Not Posted | approximately 3 years | Participants | ||||||||||||||||||||||||||||||||
| Primary | In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive | Not Posted | approximately 3 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Safety: Incidence of Adverse Events | Not Posted | approximately 3 years | Participants |
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Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.
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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 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks. | 1 | 139 | 78 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
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| Leucopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (18.0) | 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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