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Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (HBRN)
The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.
Details
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 28 |
| Start date | 2012-05 |
| Completion | 2017-02-14 |
Conditions
- Hepatitis B
Interventions
- Entecavir and peginterferon
Primary outcomes
- Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL — End of follow-up (up to 96 weeks)
Lack of data was considered to be treatment failure. - Incidence of Adverse Events (AEs) Per Person-Year of Observation — From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively. - Incidence of Serious Adverse Events (SAEs) Per Person-Year — From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Countries
United States, Canada