drugset / Trial / NCT04365933
A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect when administered to non-treated (treatment naive or off treatment) chronic Hepatitis B (CHB) patients in combination with entecavir (ETV) and pegylated interferon alpha2a (peg-IFN). An experimental treatment period of 16 weeks will be followed by a 24 week maintenance period with ETV standard of care (SoC).
Timeline
- Start
- 2020-05-25
- Primary completion
- 2021-06-16
- Completion
- 2021-11-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EYP001a | Unknown | — | Oral |
| Subject | Entecavir | Small molecule | 0.5 mg | Oral |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 90 ug | Subcutaneous |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 135 ug | Subcutaneous |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |