Hepatitis B, Chronic
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis * Elevated serum ALT \> ULN (upper limit of normal) but \</= 10 x ULN * Patients with no contra-indications to Pegasys therapy as detailed in the label * Written informed consent where local regulations allow or require it
Exclusion criteria
* Patients should not receive concomitant therapy with telbivudine * Co-infection with hepatitis A, hepatitis B or HIV * Pregnant or breastfeeding women * Patients with depression/mental diseases * Neutrophil at baseline \> 90.000/mm3 * Abnormal T4 or TSH
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment | 6 months | 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. |
| 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 | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period | Up to 24 months | 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. |
| Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period | Up to 24 months | 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. |
| Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period | Up to 24 months | 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. |
| Number of Participants With Incidence of Adverse Events | Up to 24 months | 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 |
| Incidence of Normalization of Serum Alanine Transaminase | Up to 24 months | Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range. |
| Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period | Up to 24 months | 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. |
Countries
Vietnam
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Trial terminated by sponsor | 16 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a |
|---|---|
| Age, Continuous | NA years |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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.
Time frame: 12 months
Population: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
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.
Time frame: 6 months
Population: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
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.
Time frame: Up to 24 months
Population: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
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
Time frame: Up to 24 months
Population: Participants present at the time of assessment were used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a | Number of Participants With Incidence of Adverse Events | 9 Number of participants |
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.
Time frame: Up to 24 months
Population: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
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.
Time frame: Up to 24 months
Population: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
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.
Time frame: Up to 24 months
Population: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.
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.
Time frame: Up to 24 months
Population: As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.