Hepatitis B, Chronic
Conditions
Brief summary
This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.
Interventions
Blood sampling for IL28B genotyping
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Chronic hepatitis B * Previous participation in study ML18253 * Administration of at least one dose of the study drug during ML18253 study
Exclusion criteria
* Patients not satisfying the above inclusion criteria will not be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment. |
| Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | EoF |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT and EoF |
| Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT and EoF |
| Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | EoT, as defined in the predecessor study, was at Week 48 or Week 96 |
| Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT and EoF |
| Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT and EoF |
| Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT | EoT |
Countries
Italy
Participant flow
Recruitment details
Participants in the safety analysis set included 88 patients with HBeAg-negative chronic hepatitis B enrolled at 12 study centers in Italy.
Pre-assignment details
Participants in the full analysis set included 86 previously enrolled in the predecessor study ML18253 (NCT01095835), during which they were treated.
Participants by arm
| Arm | Count |
|---|---|
| Chronic Hepatitis B Patients Interleukin 28B testing: Blood sampling for IL28B genotyping | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Chronic Hepatitis B Patients |
|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 88 |
| serious Total, serious adverse events | 0 / 88 |
Outcome results
Primary
Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)
Time frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
Population: Full analysis set (FAS), defined as all subjects who completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC | Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | 20.0 percentage of participants |
| TC | Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | 17.1 percentage of participants |
| TT | Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | 20.0 percentage of participants |
| TC+TT | Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | 17.6 percentage of participants |
| Overall | Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) | 18.6 percentage of participants |
p-value: 0.783195% CI: [0.29, 2.57]univariate logistic analysis
Primary
Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
Time frame: EoF
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC | Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | 23.1 percentage of participants |
| TC | Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | 12.9 percentage of participants |
| TT | Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | 0.0 percentage of participants |
| TC+TT | Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | 11.8 percentage of participants |
| Overall | Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF | 18.6 percentage of participants |
p-value: 0.195195% CI: [0.66, 7.67]univariate logistic analysis
Secondary
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time frame: EoT and EoF
Population: Full analysis set (FAS), defined as all subjects who completed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 2.9 percentage of participants |
| CC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 4.9 percentage of participants |
| TC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 2.4 percentage of participants |
| TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 0.0 percentage of participants |
| TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 3.9 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 2.0 percentage of participants |
| Overall | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 2.3 percentage of participants |
| Overall | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 2.3 percentage of participants |
Secondary
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time frame: EoT and EoF
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 3.8 percentage of participants |
| CC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 3.8 percentage of participants |
| TC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 0.0 percentage of participants |
| TC | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 0.0 percentage of participants |
| TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 0.0 percentage of participants |
| TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 0.0 percentage of participants |
| Overall | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 2.3 percentage of participants |
| Overall | Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 2.3 percentage of participants |
Secondary
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time frame: EoT and EoF
Population: Full analysis set (FAS), defined as all subjects who completed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 8.6 percentage of participants |
| CC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 2.9 percentage of participants |
| TC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 7.3 percentage of participants |
| TC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 4.9 percentage of participants |
| TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 0.0 percentage of participants |
| TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 3.9 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 5.9 percentage of participants |
| Overall | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoT | 7.0 percentage of participants |
| Overall | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF | EoF | 3.5 percentage of participants |
Secondary
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time frame: EoT and EoF
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 11.5 percentage of participants |
| CC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 5.8 percentage of participants |
| TC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 0.0 percentage of participants |
| TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 0.0 percentage of participants |
| TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 0.0 percentage of participants |
| TC+TT | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 0.0 percentage of participants |
| Overall | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoF | 3.5 percentage of participants |
| Overall | Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF | EoT | 7.0 percentage of participants |
Secondary
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
Time frame: EoT, as defined in the predecessor study, was at Week 48 or Week 96
Population: Full analysis set (FAS), defined as all subjects who completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | 74.3 percentage of participants |
| TC | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | 65.9 percentage of participants |
| TT | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | 50.0 percentage of participants |
| TC+TT | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | 62.7 percentage of participants |
| Overall | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) | 67.4 percentage of participants |
p-value: 0.2642Wald Chi Square
Secondary
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
Time frame: EoT
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT | 75.0 percentage of participants |
| TC | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT | 54.8 percentage of participants |
| TT | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT | 66.7 percentage of participants |
| TC+TT | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT | 55.9 percentage of participants |
| Overall | Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT | 67.4 percentage of participants |
p-value: 0.0672Wald Chi Square