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This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBeAg Negative Participants | Experimental | HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period. |
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| HBeAg Positive Participants | Experimental | HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | 180 mcg SC injection QW for 48 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) | HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests. | End of 24-weeks follow-up (Week 72) |
| Number of Participants With HBV-DNA <20,000 Copies/mL | HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests. | End of 24-weeks follow-up (Week 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HBV-DNA <400 Copies/mL | HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests. | Week 48 (end of treatment) and Week 72 (end of follow-up) |
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland | New Zealand | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | HBeAg Negative Participants | Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period. |
| FG001 | HBeAg Positive Participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed. |
| Week 48 (end of treatment) and Week 72 (end of follow-up) |
| Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level | ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter). | Week 48 (end of treatment) and Week 72 (end of follow-up) |
| Number of Participants With HBeAg Seroconversion | HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). | Week 48 (end of treatment) and Week 72 (end of follow-up) |
| Hamilton |
| New Zealand |
| New Plymouth | New Zealand |
| Riccarton, Christchurch | 8011 | New Zealand |
| Rotorua | New Zealand |
| Whangarei | New Zealand |
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. |
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| NOT COMPLETED |
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Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | HBeAg Negative Participants | HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. |
| BG001 | HBeAg Positive Participants | HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. |
| BG002 | Total | Total of all reporting groups |
| 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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| Gender | 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 HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) | HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests. | Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had one subsequent post baseline assessment. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome. | Posted | Number | participants | End of 24-weeks follow-up (Week 72) |
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| Primary | Number of Participants With HBV-DNA <20,000 Copies/mL | HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests. | ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome. | Posted | Number | participants | End of 24-weeks follow-up (Week 72) |
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| Secondary | Number of Participants With HBV-DNA <400 Copies/mL | HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests. | ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point. | Posted | Number | participants | Week 48 (end of treatment) and Week 72 (end of follow-up) |
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| Secondary | Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion | 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). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed. | ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point. | Posted | Number | participants | Week 48 (end of treatment) and Week 72 (end of follow-up) |
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| Secondary | Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level | ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter). | ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point. | Posted | Number | participants | Week 48 (end of treatment) and Week 72 (end of follow-up) |
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| Secondary | Number of Participants With HBeAg Seroconversion | HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). | ITT population. Only HBeAg positive participants was planned to be reported. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point. | Posted | Number | participants | Week 48 (end of treatment) and Week 72 (end of follow-up) |
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Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent 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 | HBeAg Negative Participants | HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. | 1 | 4 | 3 | 4 | ||
| EG001 | HBeAg Positive Participants | HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. | 0 | 20 | 7 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pain | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Mood disturbance | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Tiredness | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Itchy skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Eye infection | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Non-productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Blood in semen | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | MedDRA (Unspecified) | 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-LaRoche | 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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| Male |
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