A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-70
SponsorHuahui Health

About 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.

Eligibility criteria

Qualifiers

Willing to sign written informed consent;

Chronic HDV history with at least 6 months;

HDV RNA ≥500 IU/mL at screening;

ALT >1ULN and <10×ULN;

Disqualifiers

Concomitant decompensated cirrhosis;

Previous or current HCC or suspicion for HCC;

Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV/HBV;

Participants with active hepatitis C infection, or HIV infection;

Trial design

Treatments tested in this trial

  • Libevitug 20 mg/kg
  • Libevitug 10 mg/kg
  • Delayed treatment with libevitug

Treatment groups

160 Participants
are divided into 3 treatment groups

Sponsors and collaborators