Libevitug for chronic HDV infection: a big, international phase 3 study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an international, multicenter, randomized, open-label phase 3 trial evaluating Libevitug at two dosing levels in adults with chronic HDV infection. Participants will be assigned to Libevitug 20 mg/kg, Libevitug 10 mg/kg, or delayed treatment to assess efficacy and safety over time. Key eligibility includes confirmed HDV RNA, liver enzymes above normal but not excessively high, and ability to comply with the protocol. Exclusions include decompensated cirrhosis, active hepatocellular carcinoma or significant liver diseases not caused by HDV, and active infections such as HIV or hepatitis C. The study is led by Huahui Health with sites in the United States and China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site 201
  Garden Grove, California, United States Recruiting
• Site 101
  Changchun, Jilin, China Recruiting
• Site 104
  Kashgar, Xinjiang Uygur Autonomous Region, China Recruiting
• Site 103
  Ürümqi, Xinjiang Uygur Autonomous Region, China Recruiting
• Site 303
  Rawalpindi, Punjab Province, Pakistan Recruiting
• Site 301
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Study coordinator: Jiaying Wen PM
• Email: wenjiaying@hhhbio.com
• Phone: +86 13552466248

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.