Hepatitis B, Chronic
Conditions
Brief summary
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.
Interventions
BIOLOGICALPeginterferon alfa-2a
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
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. * Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis. * Elevated alanine aminotransferase (ALT) \> upper limit of normal (ULN) but ≤ 10 x ULN according to local label.
Exclusion criteria
* Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label. * Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV). * Concomitant treatment with telbivudine. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study | At the end of the study (Week 36) | 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). |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients | approximately 3 years | — |
| Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment | At the end of treatment (Week 24) | 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. |
| Safety: Incidence of Adverse Events | approximately 3 years | — |
| Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio | approximately 3 years | — |
| 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 | — |
Countries
Bulgaria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks. | 139 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Failure to Return | 10 |
| Overall Study | Insufficient Therapeutic Response | 4 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Missing Information | 4 |
| Overall Study | Moved to Another Center | 3 |
| Overall Study | Premature Study Termination | 26 |
| Overall Study | Principal Investigator Decision | 1 |
| Overall Study | Protocol Deviation | 2 |
| Overall Study | Reason Not Specified | 2 |
| Overall Study | Refused Treatment/Withdrew Consent | 1 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a |
|---|---|
| Age, Continuous | 40.10 years STANDARD_DEVIATION 10.45 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 139 |
| serious Total, serious adverse events | 1 / 139 |
Outcome results
Primary
In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
Time frame: approximately 3 years
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).
Time frame: At the end of the study (Week 36)
Population: Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a | Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study | 38.8 Percentage of participants |
Primary
Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
Time frame: approximately 3 years
Secondary
Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time frame: approximately 3 years
Secondary
Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time frame: approximately 3 years
Secondary
HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
Time frame: approximately 3 years
Secondary
Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
Time frame: approximately 3 years
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.
Time frame: At the end of treatment (Week 24)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment | HBeAg positive (n = 4) | 36.4 percentage of participants |
| Peginterferon Alfa-2a | Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment | HBeAg negative (n = 33) | 26.6 percentage of participants |
Secondary
Safety: Incidence of Adverse Events
Time frame: approximately 3 years