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Due to out-of-date design and non-compliance.
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This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current local labeling in routine clinical practice in Vietnam. Eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment | A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL. | 6 months |
| Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment | HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period | A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL. | Up to 24 months |
| Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HBeAg-positive chronic hepatitis B treated with Pegasys
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi | Vietnam | |||||
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Out of 335 participants planned to be enrolled in the study, only 16 participants were enrolled. The trial was conducted at 8 centers in Vietnam.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a | Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a [Pegasys] were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a | Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment | A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL. | As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected. | Posted | 6 months |
|
|
Up to 24 months
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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 with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increasing HBV DNA | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit. |
| Up to 24 months |
| Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period | HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL. | Up to 24 months |
| Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period | HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. | Up to 24 months |
| Incidence of Normalization of Serum Alanine Transaminase | Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range. | Up to 24 months |
| Number of Participants With Incidence of Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product | Up to 24 months |
| Ho Chi Minh City |
| District 5 |
| Vietnam |
| Hochiminh City | Vietnam |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| Primary | Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment | HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. | As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected. | Posted | 12 months |
|
|
| Secondary | Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period | A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL. | As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected. | Posted | Up to 24 months |
|
|
| Secondary | Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period | Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit. | As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected. | Posted | Up to 24 months |
|
|
| Secondary | Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period | HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL. | As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected. | Posted | Up to 24 months |
|
|
| Secondary | Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period | HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. | As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected. | Posted | Up to 24 months |
|
|
| Secondary | Incidence of Normalization of Serum Alanine Transaminase | Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range. | As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected. | Posted | Up to 24 months |
|
|
| Secondary | Number of Participants With Incidence of Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product | Participants present at the time of assessment were used for analysis. | Posted | Number | Number of participants | Up to 24 months |
|
|
|
| 0 |
| 16 |
| 9 |
| 16 |
| Weight loss | Investigations | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Flu symptom | Infections and infestations | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Transaminase Flare | Hepatobiliary disorders | Systematic Assessment |
|
| Libido | Psychiatric disorders | Systematic Assessment |
|
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.
| 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 |