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Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN)
The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-\<18 years old with immunotolerant chronic hepatitis B.
Details
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2012-09 |
| Completion | 2016-12-23 |
Conditions
- Hepatitis B
Interventions
- Entecavir and peginterferon
Primary outcomes
- Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL) — End of follow-up (up to 96 weeks)
- Incidence of Adverse Events (AEs) 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 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