Trial Outcomes & Findings for A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253 (NCT NCT01697501)
NCT ID: NCT01697501
Last Updated: 2017-04-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
88 participants
Primary outcome timeframe
EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
Results posted on
2017-04-10
Participant Flow
Participants in the safety analysis set included 88 patients with HBeAg-negative chronic hepatitis B enrolled at 12 study centers in Italy.
Participants in the full analysis set included 86 previously enrolled in the predecessor study ML18253 (NCT01095835), during which they were treated.
Participant milestones
| Measure |
Chronic Hepatitis B Patients
Interleukin 28B testing: Blood sampling for IL28B genotyping
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Chronic Hepatitis B Patients
Interleukin 28B testing: Blood sampling for IL28B genotyping
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253
Baseline characteristics by cohort
| Measure |
Chronic Hepatitis B Patients
n=86 Participants
Interleukin 28B testing: Blood sampling for IL28B genotyping
|
|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
"CC"
n=35 Participants
at IL28B genotype rs12979860
|
"TC"
n=41 Participants
at IL28B genotype rs12979860
|
"TT"
n=10 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=51 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
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
|
17.1 percentage of participants
|
20.0 percentage of participants
|
17.6 percentage of participants
|
18.6 percentage of participants
|
PRIMARY outcome
Timeframe: EoFPopulation: FAS
Outcome measures
| Measure |
"CC"
n=52 Participants
at IL28B genotype rs12979860
|
"TC"
n=31 Participants
at IL28B genotype rs12979860
|
"TT"
n=3 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=34 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
|
23.1 percentage of participants
|
12.9 percentage of participants
|
0.0 percentage of participants
|
11.8 percentage of participants
|
18.6 percentage of participants
|
SECONDARY outcome
Timeframe: EoT, as defined in the predecessor study, was at Week 48 or Week 96Population: Full analysis set (FAS), defined as all subjects who completed
Outcome measures
| Measure |
"CC"
n=35 Participants
at IL28B genotype rs12979860
|
"TC"
n=41 Participants
at IL28B genotype rs12979860
|
"TT"
n=10 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=51 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
|
74.3 percentage of participants
|
65.9 percentage of participants
|
50.0 percentage of participants
|
62.7 percentage of participants
|
67.4 percentage of participants
|
SECONDARY outcome
Timeframe: EoTPopulation: FAS
Outcome measures
| Measure |
"CC"
n=52 Participants
at IL28B genotype rs12979860
|
"TC"
n=31 Participants
at IL28B genotype rs12979860
|
"TT"
n=3 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=34 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
|
75.0 percentage of participants
|
54.8 percentage of participants
|
66.7 percentage of participants
|
55.9 percentage of participants
|
67.4 percentage of participants
|
SECONDARY outcome
Timeframe: EoT and EoFPopulation: Full analysis set (FAS), defined as all subjects who completed
Outcome measures
| Measure |
"CC"
n=35 Participants
at IL28B genotype rs12979860
|
"TC"
n=41 Participants
at IL28B genotype rs12979860
|
"TT"
n=10 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=51 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
EoT
|
2.9 percentage of participants
|
2.4 percentage of participants
|
0.0 percentage of participants
|
2.0 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
EoF
|
0.0 percentage of participants
|
4.9 percentage of participants
|
0.0 percentage of participants
|
3.9 percentage of participants
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: EoT and EoFPopulation: FAS
Outcome measures
| Measure |
"CC"
n=52 Participants
at IL28B genotype rs12979860
|
"TC"
n=31 Participants
at IL28B genotype rs12979860
|
"TT"
n=3 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=34 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
EoT
|
3.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
EoF
|
3.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: EoT and EoFPopulation: Full analysis set (FAS), defined as all subjects who completed
Outcome measures
| Measure |
"CC"
n=35 Participants
at IL28B genotype rs12979860
|
"TC"
n=41 Participants
at IL28B genotype rs12979860
|
"TT"
n=10 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=51 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
EoT
|
8.6 percentage of participants
|
7.3 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
EoF
|
2.9 percentage of participants
|
4.9 percentage of participants
|
0.0 percentage of participants
|
3.9 percentage of participants
|
3.5 percentage of participants
|
SECONDARY outcome
Timeframe: EoT and EoFPopulation: FAS
Outcome measures
| Measure |
"CC"
n=52 Participants
at IL28B genotype rs12979860
|
"TC"
n=31 Participants
at IL28B genotype rs12979860
|
"TT"
n=3 Participants
at IL28B genotype rs12979860
|
"TC+TT"
n=34 Participants
at IL28B genotype rs12979860
|
"Overall"
n=86 Participants
at IL28B genotype rs12979860
|
|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
EoT
|
11.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
EoF
|
5.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.5 percentage of participants
|
Adverse Events
Chronic Hepatitis B Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER