Clinical Trials in the USA / NCT07499544
Recruiting
Phase 3
A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
NCT07499544 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Chronic Hepatitis D Infection
Investigational drug(s) / intervention(s)
Libevitug 20 mg/kgLibevitug 10 mg/kgDelayed treatment with libevitug
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
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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 — Week 48
Proportion of participants with HDV RNA below Lower Limit of Quantification (LLOQ) with target not detected (TND) or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Site 201 | Garden Grove | California | Recruiting |
| Site 101 | Changchun | Jilin | Recruiting |
| Site 104 | Kashgar | Xinjiang Uygur Autonomous Region | Recruiting |
| Site 103 | Ürümqi | Xinjiang Uygur Autonomous Region | Recruiting |
| Site 303 | Rawalpindi | Punjab Province | Recruiting |
| Site 301 | Karachi | Sindh | Recruiting |
| Site 302 | Karachi | Sindh | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07499544 on ClinicalTrials.gov ↗ ← All trials in the USA