160 Participants NeededMy employer runs this trial

Libevitug for Hepatitis D

Recruiting at 7 trial locations
JW
Overseen ByJiaying Wen PM
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Huahui Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.

Are You a Good Fit for This Trial?

This trial is for adults with chronic hepatitis D infection for at least 6 months, who have a certain level of the virus in their blood and mildly to moderately elevated liver enzymes. Participants must be able to follow study instructions and give consent.

Inclusion Criteria

I am willing to sign a consent form for the study.
I have had chronic hepatitis D for at least 6 months.
I have an HDV RNA level of at least 500 IU/mL.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Libevitug

Trial Overview

The study is testing two different doses of a drug called libevitug (10 mg/kg or 20 mg/kg) compared to delayed treatment. Participants are randomly assigned to groups, and everyone knows which treatment they receive.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Libevitug 20 mg/kgExperimental Treatment1 Intervention
Group II: Libevitug 10 mg/kgExperimental Treatment1 Intervention
Group III: Control group/delayed treatment with libevitug 20 mg/kgActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Huahui Health

Lead Sponsor

Trials
11
Recruited
1,900+