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RecruitingPhase 3

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

Huahui Health · NCT07499544

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
160
US sites recruiting
1
Study start
April 22, 2026
Record last updated
August 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Libevitug 20 mg/kg; Libevitug 10 mg/kg; Delayed treatment with libevitug

Conditions: Chronic Hepatitis D Infection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Jiaying Wen PM · +86 13552466248 · wenjiaying@hhhbio.com
A Phase III Study to Evaluate the Efficacy and Safety of Libevitug… (NCT07499544) | Bored Studies