Recruiting
Phase 3

Libevitug

Sponsor:

Huahui Health

Code:

NCT07499544

Conditions

Chronic Hepatitis D Infection

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

Interventions

Libevitug 20 mg/kg

Libevitug 10 mg/kg

Delayed treatment with libevitug

Study Details

Brief summary:

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.

Conditions

Chronic Hepatitis D Infection

Study ID

NCT07499544

Start date

Apr 22, 2026

Status verified date

Jun, 2026

Completion date

Jan 29, 2030

Anticipated

Primary completion date

Sep 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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;
  • Able to communicate well and comply with protocol.

Exclusion Criteria:

  • 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;
  • Alcohol abuse or drug addiction within 1 year;
  • Participants have participated in other clinical trial within 1 month;
  • Pregnant, lactating women.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Libevitug 20 mg/kg

Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks

experimental: Libevitug 10 mg/kg

Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks

active comparator: Control group/delayed treatment with libevitug 20 mg/kg

Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks

Interventions

Libevitug 20 mg/kg

Route of administration: intravenous infusion

Libevitug 10 mg/kg

Route of administration: intravenous infusion

Delayed treatment with libevitug

Route of administration: intravenous infusion

Primary outcome measure

  • Proportion of participants with HDV RNA below LLOQ with TND or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period [ Time Frame: Week 48 ]

Central Contacts and Locations

Central contacts

Jiaying Wen PM

+86 13552466248wenjiaying@hhhbio.com

Locations

Site 201

Recruiting

Garden Grove, California, United States, 92844

More Information

Sponsor

Huahui Health

Last update posted

Aug 24, 2026

Last verified

Jun, 2026

Keywords

  • Hepatitis Delta Virus (HDV)
  • Viral hepatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Huahui Health on 2026-08-24.