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

RecruitingPhase 3Ages 12 Years - 70 YearsAllHuahui Health
NCT07499544 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

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

7 sites
Site 201
Garden Grove, United States
Site 101
Changchun, China
Site 104
Kashgar, China
Site 103
Ürümqi, China
Site 303
Rawalpindi, Pakistan
Site 301
Karachi, Pakistan
Site 302
Karachi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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