NCT03852719

Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)

A Multicenter, Open-label, Randomized Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis Delta

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of bulevirtide administered subcutaneously (SC) for 48 weeks at a dose of 2 mg or 10 mg once daily for treatment of chronic hepatitis delta (CHD) in comparison to delayed treatment. The main goal of this study is to determine the effectiveness of bulevirtide in participants randomized to bulevirtide 2 mg or 10 mg once daily SC as compared to participants randomized to delayed treatment for 48 weeks. Treatment will continue through Week 144 (participants randomized to delayed treatment will change to bulevirtide 10 mg once daily SC after Week 48 through Week 144). All participants will be followed off-treatment for an additional 96 weeks.

Conditions

• Chronic Hepatitis Delta

Interventions

Type	Name	Description
DRUG	Bulevirtide	Administered via SC injections

Timeline

• Start date: 2019-04-17
• Primary completion: 2020-11-26
• Completion: 2024-08-08
• First posted: 2019-02-25
• Last updated: 2025-08-22
• Results posted: 2022-10-28

Locations

19 sites across 5 countries: United States, Germany, Italy, Russia, Sweden

Regulatory

• FDA-regulated drug study