Phase 3
N=128
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01095835 ↗Enrolled (actual)
128
Serious AEs
12.6%
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period — 11.8; 25.0; 20.0 percentage of participants — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg (Drug); Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg (Drug); Lamivudine (LAM) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period |
11.8; 25.0; 20.0 | 0.08 |
| SECONDARY Percentage of Participants Achieving the Combined Response at the End of Treatment |
29.4; 38.5; 32.0 | — |
| SECONDARY Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up |
23.5; 28.8; 24.0 | — |
| SECONDARY Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL |
29.4; 38.5; 28.0; 21.6; 26.9; 20.0 | — |
| SECONDARY Percentage of Participants Achieving Histological Response |
13.7; 5.8; 8.0 | — |
| SECONDARY Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment |
9642.6; 7229.8; 8981.0; -2801.1; -2282.1; -3121.2 | — |
| SECONDARY Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy |
— | — |
Summary
This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adults 18-70 years of age;
- HBeAg-negative chronic hepatitis B for >/=6 months;
- liver disease consistent with chronic hepatitis B.
Exclusion Criteria
- interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy </=12 months before first dose of study drug;
- non-responders to previous interferon therapy;
- co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);
- hepatocellular cancer;
- compensated (Child A, score 6) or decompensated liver disease (Child B or C).
Data sourced from ClinicalTrials.gov (NCT01095835). 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.