Phase 3
Completed N=88
A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT01697501 ↗
Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: 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; 17.1; 20.0; 17.6 percentage of participants — p=0.7831
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
20.0; 17.1; 20.0; 17.6; 18.6 | 0.7831 |
| PRIMARY Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF |
23.1; 12.9; 0.0; 11.8; 18.6 | 0.1951 |
| SECONDARY Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT) |
74.3; 65.9; 50.0; 62.7; 67.4 | 0.2642 |
| SECONDARY Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT |
75.0; 54.8; 66.7; 55.9; 67.4 | 0.0672 |
| SECONDARY Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF |
2.9; 2.4; 0.0; 2.0; 2.3; 0.0 | — |
| SECONDARY Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF |
3.8; 0.0; 0.0; 0.0; 2.3; 3.8 | — |
| SECONDARY Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF |
8.6; 7.3; 0.0; 5.9; 7.0; 2.9 | — |
| SECONDARY Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF |
11.5; 0.0; 0.0; 0.0; 7.0; 5.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01697501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.